Canadian Humira Post Marketing Observational NCT01387815

Clinical Trial Details — Status: Completed

Administrative data
NCT number	NCT01387815
Other study ID #	P12-678
Secondary ID
Status	Completed
Phase
First received
Last updated
Start date	August 16, 2011
Est. completion date	June 29, 2018

Study information
Verified date	November 2019
Source	AbbVie
Contact	n/a
Is FDA regulated	No
Health authority
Study type	Observational

Clinical Trial Summary

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design that compared the real - life effectiveness of adalimumab to topical and traditional systemic agents in the management of psoriasis and its impact on the patient's quality of life and societal burden of illness.

Description:

This was a Canadian post-marketing observational study (PMOS) utilizing a prospective cohort design. Participants were entered into one of two study cohorts (adalimumab cohort or topical/traditional systemic cohort) at the time of change of their psoriasis treatment for any reason and were followed for a maximum of 24 months with recommended assessments at 3, 6, 12, 18 and 24 months after baseline. Treatment of the participants and follow up were according to the physician's judgment, regional regulations, and the product monograph. Off-label use was not permitted, and these participants were not included in the study. Dose changes including escalation were allowed as per the physician's judgment for participants that were treated as per indication when they were enrolled in the study.

Recruitment information / eligibility
Status	Completed
Enrollment	662
Est. completion date	June 29, 2018
Est. primary completion date	June 29, 2018
Accepts healthy volunteers	No
Gender	All
Age group	18 Years and older
Eligibility	Inclusion Criteria: - Active moderate or severe plaque psoriasis according to the judgment of the treating physician. - The treating physician has decided to change the current treatment or add additional treatments for any reason including but not limited to inadequate response, intolerance, sub-optimal compliance or participant preference. Exclusion Criteria: - Had currently participated in another prospective study with similar objectives. - Participant could not or would not sign informed consent. - Presence of other condition that, in the opinion of the treating physician, prohibits the participant from participating in the study or obscured the assessment of the treatment of plaque psoriasis.

Study Design

Related Conditions & MeSH terms

Psoriasis

Intervention

Biological:
• Adalimumab
Adalimumab administered by subcutaneous injection.

Locations
Country	Name	City	State
Canada	SimcoDerm Medical and Surgical /ID# 96915	Barrie	Ontario
Canada	Maritime Medical Reseach Cente /ID# 128775	Bathurst	New Brunswick
Canada	Jason Ronald Sneath Medical Co /ID# 138026	Brandon	Manitoba
Canada	Institute for Skin Advancement /ID# 66782	Calgary	Alberta
Canada	Kirk Barber Research, CA /ID# 57722	Calgary	Alberta
Canada	Richmond Road Diagnostic Treat /ID# 70913	Calgary	Alberta
Canada	Dr. Isabelle Delorme Inc. /ID# 57791	Drummondville	Quebec
Canada	Alberta DermaSurgery Centre /ID# 75513	Edmonton	Alberta
Canada	Thomas Nakatsui P.C. /ID# 55080	Edmonton	Alberta
Canada	Kingsway Clinical Research /ID# 97255	Etobicoke	Ontario
Canada	Dr. Irina Turchin PC Inc. /ID# 66029	Fredericton	New Brunswick
Canada	Eastern Canada Cutaneous Resea /ID# 46353	Halifax	Nova Scotia
Canada	Dermatrials Research /ID# 124138	Hamilton	Ontario
Canada	Dr. Wei Jing Loo Medicine Prof /ID# 127546	London	Ontario
Canada	Lynderm Research Inc. /ID# 63206	Markham	Ontario
Canada	Dr. Anna Hinek Medicine Prof /ID# 148305	Mississauga	Ontario
Canada	Toronto Regional Wound Healing /ID# 55135	Mississauga	Ontario
Canada	Dermatologue Inc. /ID# 76074	Moncton	New Brunswick
Canada	Dre. Angelique Gagne-Henley /ID# 125204	Montreal	Quebec
Canada	Wellington Medical Clinic Ltd. /ID# 55083	Nanaimo	British Columbia
Canada	Oakville Derma and Laser, CA /ID# 55130	Oakville	Ontario
Canada	Dr. Melinda Gooderham Medicine /ID# 54566	Peterborough	Ontario
Canada	Dr. Loukia-Maria Mitsos /ID# 124156	Pierrefonds	Quebec
Canada	Douglas N. Keeling MD Dermatol /ID# 55098	Quispamsis	New Brunswick
Canada	York Dermatology Center /ID# 127786	Richmond Hill	Ontario
Canada	Royal Univ. Hosp, Saskatoon,CA /ID# 74613	Saskatoon	Saskatchewan
Canada	Specialized Dermatology Inc. /ID# 64031	St-catharines	Ontario
Canada	Karma Clinical Trials /ID# 55101	St. John's	Newfoundland and Labrador
Canada	Nexus Clinical Research /ID# 56403	St. John's	Newfoundland and Labrador
Canada	Giroux, Sudbury, CA /ID# 55128	Sudbury	Ontario
Canada	Lori Shapiro Medicine Prof Inc /ID# 55126	Thornhill	Ontario
Canada	Toronto Dermatology Centre /ID# 55127	Toronto	Ontario
Canada	Dermatologie Sima Inc. /ID# 54922	Verdun	Quebec
Canada	Percuro Clinical Research, Ltd /ID# 54563	Victoria	British Columbia
Canada	Dr. Beatrice Wang /ID# 63242	Westmount	Quebec
Canada	Winnipeg Clinic, Manitoba, CA /ID# 56865	Winnipeg	Manitoba

Sponsors *(3)*
Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Cato Research, JSS Medical Research Inc.

Country where clinical trial is conducted

Canada,

Outcome
Type	Measure	Description	Time frame
Primary	Percentage of Participants With a Physician Global Assessment (PGA) Score =1 at Month 6	The Physician global assessment (PGA) score is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of intent to treat (ITT) participants who attended each visit.	Month 6
Secondary	Time to Achieving PGA = 1	The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity.	Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary	PGA=1: Percentage of Participants at Month 3	The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.	Month 3
Secondary	PGA=1: Percentage of Participants at Month 12	The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.	Month 12
Secondary	PGA=1: Percentage of Participants at Month 18	The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.	Month 18
Secondary	PGA=1: Percentage of Participants at Month 24	The PGA is an assessment by the investigator of the overall disease severity at the time of evaluation. The PGA uses a 6-point scale. The degree of overall lesion severity was evaluated using the following categories: 0 (Clear): No evidence of scaling or plaque elevation; erythema may be present; 1 (Minimal): scaling may be present, up to moderate erythema, minimal plaque elevation; 2 (Mild): Fine scaling, up to moderate erythema, slight plaque elevation; 3 (Moderate): Coarse scale dominates, moderate erythema, moderate plaque elevation; 4 (Severe): Coarse non-tenacious scale dominates, severe erythema, marked plaque elevation; 5 (Very Severe): Very coarse thick tenacious scale predominates, very severe erythema, severe plaque elevation. A higher score indicates greater disease severity. Percentages based on the total number of ITT participants who attended each visit.	Month 24
Secondary	Psoriasis and Arthritis Screening Questionnaire (PASQ) Total Score: Change From Baseline to Month 3	PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.	Baseline, Month 3
Secondary	PASQ Total Score: Change From Baseline to Month 6	PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.	Baseline, Month 6
Secondary	PASQ Total Score: Change From Baseline to Month 12	PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.	Baseline, Month 12
Secondary	PASQ Total Score: Change From Baseline to Month 18	PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.	Baseline, Month 18
Secondary	PASQ Total Score: Change From Baseline to Month 24	PASQ is an 11-item tool that ascertains self-reported presence of joint pain and swelling by the participant. The PASQ questionnaire consists of 10 questions for which a positive and negative response are assigned a score of 1 or 2, and 0, respectively. The maximum score is 10. In addition, participants were also asked to indicate on a diagram where they experienced joint swelling or pain. The diagram was scored 0, 1, 3, or 5, depending on the distribution of the participants' markings. The final composite score for the PASQ ranges from 0 to a maximum of 15. A decrease indicates improvement.	Baseline, Month 24
Secondary	Body Surface Area of Psoriasis Involvement: Change From Baseline to Month 6	The Body Surface Area (BSA) is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.	Baseline, Month 6
Secondary	BSA of Psoriasis Involvement: Change From Baseline to Month 12	The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.	Baseline, Month 12
Secondary	BSA of Psoriasis Involvement: Change From Baseline to Month 18	The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.	Baseline, Month 18
Secondary	BSA of Psoriasis Involvement: Change From Baseline to Month 24	The BSA is an indicator of disease severity and the affected area is expressed as a percentage of the total body surface area.The BSA affected by psoriasis was measured by the physician selecting the participant's right or left hand as the measuring device. For purposes of clinical estimation, the total surface of the palm plus 5 digits was to be assumed to be approximately equivalent to 1% BSA. Measurement of the total area of involvement by the physician was aided by imagining if scattered plaques were moved so that they were next to each other and then estimated the total area involved. A decrease in BSA affected by psoriasis indicates improvement.	Baseline, Month 24
Secondary	Patient Global Assessment (PtGA) of Disease Activity Based on a Visual Analog Scale (VAS): Change From Baseline to Month 3	Patient Global Assessment of disease activity (PtGA) was assessed using a visual analog scale (VAS) where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.	Baseline, Month 3
Secondary	PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 6	PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.	Baseline, Month 6
Secondary	PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 12	PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.	Baseline, Month 12
Secondary	PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 18	PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.	Baseline, Month 18
Secondary	PtGA of Disease Activity Based on a VAS: Change From Baseline to Month 24	PtGA of disease activity was assessed using a VAS where 0 indicates doing very well with respect to arthritis and/or skin psoriasis and a value of 100 indicates doing very poorly.	Baseline, Month 24
Secondary	Dermatology Quality of Life Index (DLQI) Total Score: Change From Baseline to Month 3	The Dermatology Quality of Life Index (DLQI) is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 3
Secondary	DLQI Total Score: Change From Baseline to Month 6	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 6
Secondary	DLQI Total Score: Change From Baseline to Month 12	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 12
Secondary	DLQI Total Score: Change From Baseline to Month 18	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 18
Secondary	DLQI Total Score: Change From Baseline to Month 24	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 24
Secondary	Time to Achieving DLQI =1	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference.	Baseline, Month 3, Month 6, Month 12, Month 18, and Month 24
Secondary	DLQI =1: Percentage of Participants at Month 3	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.	Month 3
Secondary	DLQI =1: Percentage of Participants at Month 6	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.	Month 6
Secondary	DLQI =1: Percentage of Participants at Month 12	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.	Month 12
Secondary	DLQI =1: Percentage of Participants at Month 18	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.	Month 18
Secondary	DLQI =1: Percentage of Participants at Month 24	The DLQI is a 10-question questionnaire that asks the participant to evaluate the degree that psoriasis has affected their quality of life in the last week and includes 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Responses to each domain are not relevant (0), not at all (0), a little (1), a lot (2), and very much (3). The DLQI is calculated by summing the scores of the questions and ranges from 1 to 30, where 0-1 = no effect on participant's life, 2-5 = small effect, 6-10 = moderate effect, 11-20 = very large effect, and 21-30 = extremely large effect on participant's life. The higher the score, the more the participant's quality of life is impaired. A 5-point change from baseline is considered a clinically important difference. Percentage based on the total number of ITT participants who attended each visit.	Month 24
Secondary	Beck Depression Inventory II (BDI-II): Change From Baseline to Month 6	The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex. The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63. The higher the score, the greater the severity of the depression.	Baseline, Month 6
Secondary	BDI-II: Change From Baseline to Month 12	The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex. The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63. The higher the score, the greater the severity of the depression.	Baseline, Month 12
Secondary	BDI-II: Change From Baseline to Month 24	The Beck Depression inventory assesses the presence and severity of depression and responsiveness to treatment. It consists of 21 items converging on 2 scales measuring somatic and affective components of depression. The questions assess hopelessness and irritability, cognition such as guilt or feelings of being punished, as well as physical symptoms such as fatigue, weight loss, and loss of interest in sex. The total score ranges from a minimum of 0 to a maximum of 63 with the following suggested score interpretations: minimal range = 0-13, mild depression = 14-19, moderate depression = 20-28, and severe depression = 29-63. The higher the score, the greater the severity of the depression.	Baseline, Month 24
Secondary	Medical Outcomes Study Short Form-12 Health Status Survey (SF-12) Mental Component Summary (MCS) Score: Change From Baseline to Month 6	The Medical Outcomes Study Short Form 12 (SF-12) questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 6
Secondary	SF-12 MCS Score: Change From Baseline to Month 12	The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 12
Secondary	SF-12 MCS Score: Change From Baseline to Month 24	The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 5-8 comprise the mental component of the SF-12. Scores on each item were summed and averaged (MCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 24
Secondary	SF-12 Physical Component Summary (PCS) Score: Change From Baseline to Month 6	The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 6
Secondary	SF-12 PCS Score: Change From Baseline to Month 12	The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 12
Secondary	SF-12 PCS Score: Change From Baseline to Month 24	The SF-12 questionnaire is a shortened form (12 items) of the SF-36 Health Survey generic quality of life questionnaire that assesses eight health concepts: 1) limitations in physical functioning due to health problems; 2) limitations in usual role because of physical health problems; 3) bodily pain; 4) general health perceptions; 5) vitality (energy and fatigue); 6) limitations in social functioning because of physical or emotional problems; 7) limitations in usual role due to emotional problems; and 8) general mental health (psychological distress and well-being). Items 1-4 comprise the physical component of the SF-12. Scores on each item were summed and averaged (PCS Score; range = 0-100); a positive change from Baseline indicates improvement.	Baseline, Month 24
Secondary	Work Limitation Questionnaire (WLQ) Total Score: Change From Baseline to Month 6	The Work Limitation Questionnaire (WLQ) is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 6
Secondary	WLQ Total Score: Change From Baseline to Month 12	The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 12
Secondary	WLQ Total Score: Change From Baseline to Month 24	The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 24
Secondary	WLQ Productivity Loss Score: Change From Baseline to Month 6	The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 6
Secondary	WLQ Productivity Loss Score: Change From Baseline to Month 12	The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 12
Secondary	WLQ Productivity Loss Score: Change From Baseline to Month 24	The WLQ is a self-administered questionnaire comprised of 25 questions. The WLQ evaluates the participant's overall ability to work in the last two weeks. It comprises 25 questions each with a range of 100% ('all of the time') to 0% ('none of the time') where 6 represents non-applicability to the patient's line of work. The WLQ Productivity Loss Score indicates the percentage decrement in work output due to health problems. The WLQ Productivity Loss score is based on a weighted sum of the scores from the 4 WLQ scales (Time, Physical, Mental-Interpersonal, and Output). The resulting score (known as the WLQ Index) is in the form of the natural log of work productivity. The final step needed to generate the WLQ Productivity Loss Score is to convert the WLQ Index score to a percentage. The higher the score, the greater the work limitation.	Baseline, Month 24
Secondary	Healthcare Resource Utilization (HCRU): Number of Participants With Insurance for Prescription Medication at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants With Insurance for Prescription Medication at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants With Insurance for Prescription Medication at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants by Type of Insurance for Prescription Medication at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for Ankylosing Spondylitis (AS) at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Seeking Health Care in the Past 4 Weeks for AS at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Extra or Unscheduled Visits the (Office/Clinic) of the Study Doctor for AS at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Visits to Another Physician at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Visits to Another Physician at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Visits to Another Physician at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Visits to Another Physician at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Visits to Another Physician at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Visits to Another Physician at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Visits to a Healthcare Professional at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Visits to A Healthcare Professional at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Visits to A Healthcare Professional at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Visits to A Healthcare Professional at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Visits to a Hospital Emergency Room at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Visits to a Hospital Emergency Room at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Visits to a Hospital Emergency Room at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Visits to a Hospital Emergency Room at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Use of an Ambulance Service at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Use of an Ambulance Service at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Use of an Ambulance Service at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Making Complementary/Alternate Therapy Visits at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Complementary/Alternate Therapy Visits at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Complementary/Alternate Therapy Visits at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Complementary/Alternate Therapy Visits at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Hospitalized in the Past 4 Weeks at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Length of Hospital Stay for Those Participants Hospitalized at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Number of Participants Admitted to the Intensive Care Unit (ICU) in the Past 4 Weeks at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Number of Participants Admitted to the ICU in the Past 4 Weeks at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payment for Over the Counter Medications at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payment for Over the Counter Medications at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payment for Over the Counter Medications at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payments to Healthcare Professionals at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payments to Healthcare Professionals at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payments to Healthcare Professionals at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payments for Medical Procedures or Laboratory Tests at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payments for Medical Devices at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payments for Medical Devices at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payments for Medical Devices at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payments for Health Care or Extra Help at Home at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	HCRU: Cost of Payments for Transportation at Month 6	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 6
Secondary	HCRU: Cost of Payments for Transportation at Month 12	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 12
Secondary	HCRU: Cost of Payments for Transportation at Month 24	Participants were asked at Month 6, Month 12, and Month 24 about having insurance for prescription medication (and type of insurance) and their utilization of healthcare resources within the 4 weeks prior to study visits: seeking health care for AS, including extra/unscheduled office visits to their study doctor (and number of visits among those reporting =1 visit), visits to another doctor (and number of visits among those reporting =1 visit), visits to healthcare professional (and number of visits among those reporting =1 visit), visits to hospital emergency room (and number of visits among those reporting =1 visit), use of ambulant service, complementary/alternate therapy visits (and number of visits among those reporting =1 visit), hospital admissions (and length of hospital stay), ICU admissions, over the counter medications, payments for healthcare professionals, medical procedures or laboratory tests, medical devices, health care or extra help at home, and transportation costs.	Month 24
Secondary	Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 3
Secondary	Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 6
Secondary	Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 12
Secondary	Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 18
Secondary	Topical Treatment Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 24
Secondary	Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 3	Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.	Month 3
Secondary	Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 6	Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.	Month 6
Secondary	Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 12	Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.	Month 12
Secondary	Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 18	Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.	Month 18
Secondary	Phototherapy Session Patient Reported Treatment Compliance: Number of Missed Sessions Since Last Visit Assessed at Month 24	Phototherapy sessions for psoriasis compliance by the participant was assessed by a self administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24 as part of the psoriasis treatment compliance questionnaire. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician.	Month 24
Secondary	Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 3
Secondary	Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 6
Secondary	Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 12
Secondary	Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 18
Secondary	Traditional Systemic Agent Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 24
Secondary	Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 3	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 3
Secondary	Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 6	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 6
Secondary	Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 12	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 12
Secondary	Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 18	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 18
Secondary	Adalimumab Injection Patient Reported Treatment Compliance: Number of Missed Doses Since Last Visit Assessed at Month 24	Psoriasis treatment compliance by the participant was assessed by a self-administered questionnaire and interview by the treating physician at Month 3, 6, 12, 18, and 24. Participants were asked to complete the baseline set of questionnaires while at the physician's office. Thereafter, participants completed the questionnaires themselves and either mailed them to the data management center or returned them to the treating physician. The questions included the number missed since the last visit of: applications for topical medication; phototherapy sessions; doses of traditional systemic agents; and adalimumab injections.	Month 24
Secondary	Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 3	Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.	Month 3
Secondary	Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 6	Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.	Month 6
Secondary	Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 12	Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.	Month 12
Secondary	Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 18	Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.	Month 18
Secondary	Medical History: Number of Participants With Any Relevant Physical Changes Since the Last Visit at Month 24	Changes in medical history were assessed by the treating physician since the last visit at Month 3, 6, 12, 18, and 24. A global assessment of physical changes per standard of care was recorded for each participant as "yes", "no", "not done" or missing.	Month 24
Secondary	Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 3	Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.	Month 3
Secondary	Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 6	Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.	Month 6
Secondary	Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 12	Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.	Month 12
Secondary	Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 18	Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.	Month 18
Secondary	Concomitant Medication: Number of Participants With Any Changes in Psoriasis Medication/Treatment Since the Last Visit at Month 24	Change in concomitant medication use by the participant was defined as any treatment, whether prescription or over the counter, used by the participant for psoriasis before and during the study. Details were recorded in the Case Report Form by the investigator and included dose, frequency, and duration of treatment and route. Change was assessed by treating physician per standard of care at Month 3, 6, 12, 18, and 24. A global assessment of change was recorded for each participant as "yes", "no", "not done" or missing.	Month 24

See also
Status	Clinical Trial	Phase
Completed	`NCT03236870` - A Study to Evaluate the Effectiveness and Patient-Reported Outcome of Adalimumab in Patients With Moderate to Severe Plaque Psoriasis in China
Completed	`NCT00078819` - Etanercept (Enbrel®) in Psoriasis - Pediatrics	Phase 3
Completed	`NCT04841187` - Assessing the Long Term Effectiveness and Safety of Systemic Treatments in Cutaneous Psoriasis
Active, not recruiting	`NCT03927352` - The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis	Phase 3
Completed	`NCT03284879` - Post-Marketing Surveillance Study of OTEZLA
Recruiting	`NCT06027034` - Effectiveness of a Digital Health Application for Psoriasis	N/A
Not yet recruiting	`NCT06050330` - CD4+ T Cells and S100A7 Epression in Normal and Psoriatic Skin: A Histological and Histochemical Study	N/A
Recruiting	`NCT05744466` - A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Completed	`NCT04149587` - A Study of Brodalumab (SILIQ®) in Psoriasis Participants With Inadequate Response to Their Current Biologic Agent Regimen
Completed	`NCT01384630` - Safety, Pharmacokinetics, and Efficacy of RA-18C3 in Subjects With Moderate to Severe Psoriasis	Phase 2
Completed	`NCT03998683` - A Study of Guselkumab for the Treatment of Palmoplantar-non-Pustular Psoriasis	Phase 3
Terminated	`NCT03556202` - A Long-term Study to Evaluate Safety and Maintenance of Treatment Effect of LY3074828 in Participants With Moderate-to-Severe Plaque Psoriasis (OASIS-3)	Phase 3
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06077331` - A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis	Phase 2
Completed	`NCT04316585` - A Study to Evaluate the Benefit and Safety of GSK2982772 in Moderate to Severe Psoriasis Participants	Phase 1
Completed	`NCT04894890` - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed	`NCT00358384` - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034	Phase 1
Completed	`NCT03757013` - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed	`NCT03265613` - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis	Phase 1/Phase 2
Completed	`NCT05003531` - A Study to Evaluate IBI112 in the Treatment of Subjects With Moderate to Severe Plaque Psoriasis	Phase 2

External Links

Link

Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Psoriasis

Clinical Trial Details — Status: Completed

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Intervention

Locations

Sponsors (3)

Country where clinical trial is conducted

Outcome

External Links