A Long Term Study To Evaluate The Safety, Tolerability And Efficacy Of CP-690,550 In Patients With Moderate To Severe Plaque Psoriasis And/Or Psoriatic Arthritis

Psoriasis Clinical Trial

Official title:

A Phase 3, Multi Site, Randomized, Double Blind Study Of The Long-term Safety, Tolerability And Efficacy Of 2 Oral Doses Of Cp 690,550 In Subjects With Moderate To Severe Plaque Psoriasis And/or Psoriatic Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01519089
• Other study ID #: A3921137
• Status: Completed
• Phase: Phase 3
• First received: December 22, 2011
• Last updated: August 6, 2015
• Start date: March 2012
• Est. completion date: January 2014

Study information

• Verified date: August 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to evaluate the long term safety of CP-690,550 in patients being treated for moderate to severe plaque psoriasis and/or psoriatic arthritis. This study will also to compare the efficacy of two oral doses of CP-690,550 (5 mg BID and 10 mg BID) after 16 weeks of treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Are 20 years or older and considered to be candidates for systemic or phototherapy.

[Moderate to Severe Plaque Psoriasis]

• Diagnosed for at least 12 months.

• Have Psoriasis Area and Severity Index (PASI) score of 12 and plaque type psoriasis covering at least 10% of body surface area (BSA).

[Psoriatic Arthritis]

• Diagnosed for at least 6 months.

• Meet the CASPAR (classification criteria for Psoriatic Arthritis) criteria at screening;

• Have active arthritis (=3 tender/painful joints on motion and =3 swollen joints), and active plaque psoriasis with at least 2 cm in diameter.

Exclusion Criteria:

• Non-plaque or drug induced forms of psoriasis

• Cannot discontinue current oral, injectable or topical therapy for psoriasis/psoriatic arthritis or cannot discontinue phototherapy (PUVA or UVB)

• any uncontrolled significant medical condition

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis, Psoriatic
• Psoriasis

Intervention

Drug:
• CP-690,550
10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
• CP-690, 550
5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.

Locations

Country	Name	City	State
Japan	Tokyo Teishin Hospital	Chiyoda-ku	Tokyo
Japan	Kobe University Hospital	Chuo-ku, Kobe	Hyogo
Japan	Fukuoka University Hospital	Fukuoka
Japan	Fukushima Medical University Hospital	Fukushima
Japan	Tokyo medical university Hachioji medical center	Hachioji	Tokyo
Japan	Kanazawa Medical University Hospital	Kahoku-gun	Ishikawa
Japan	Yamanashi Prefectural Central Hospital	Kofu	Yamanashi
Japan	University of Miyazaki Hospital	Miyazaki-shi	Miyazaki
Japan	Nissay Hospital	Osaka
Japan	National Hospital Organization Sagamihara National Hospital	Sagamihara	Kanagawa
Japan	JR Sapporo hospital	Sapporo	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Kanto Medical Center NTT East Corporation	Shinagawa-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjyuku-ku	Tokyo
Japan	Jikei University Hospital	Tokyo
Japan	Tonami General Hospital	Tonami	Toyama

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response at Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at Week 16 relative to Baseline.	Week 16	No
Primary	Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' at Week 16	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 16	No
Primary	Proportion of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 16	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 16	No
Primary	Number of Participants With Adjudicated Cardiovacular Events	Adjudicated cardiovascular events were assessed by investigators as independent reviewers based on event documentation including: hospital discharge summaries, operative reports, clinic notes, ECGs, diagnostic enzymes, results of other diagnostic tests, autopsy reports and death certificate information; specific requirements vary with the event requiring adjudication.	Baseline to Follow-up	Yes
Primary	Number of Participants With Malignancy Events _Week 0 Through Follow-up	For all biopsies of potentially malignant tumors, suspicious lymphadenopathy, or possible extranodal LPD, the study site requested the pathologist to send the original slides used to make the definitive diagnosis, ancillary study reports, and the pathologist's report to the central laboratory for a blinded review by a central pathologist.	Baseline to Follow-up	Yes
Secondary	Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI at the each visit relative to Baseline.	Week 2, 4, 8, 12, 20, 28, 40, 52	No
Secondary	Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least a 50 percent (%) reduction in PASI at the each visit relative to Baseline.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Percentage of Participants With a Psoriasis Area and Severity Index 90 (PASI90) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least a 90 percent (%) reduction in PASI at the each visit relative to Baseline.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Time to Achieve a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Median time to achieve a PGA response up to week 16 is reported. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Week 16	No
Secondary	Time to Achieve a Psoriasis Area and Severity Index 75 (PASI75) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least 75% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Week 16	No
Secondary	Time to Achieve a Psoriasis Area and Severity Index 50 (PASI50) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI50 response was defined as at least 50% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Week 16	No
Secondary	Time to Achieve a Psoriasis Area and Severity Index 90 (PASI90) Response	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and "percent of BSA" affected. PASI is a composite scoring assessed by the investigator, of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI90 response was defined as at least 90% reduction in PASI relative to Baseline. The median time to event is estimated based on Kaplan-Meier product-limit method. Median time to event is not estimable if the estimated probability of response by Week 16 is less than 50%.	Week 16	No
Secondary	Percentage of Participants With a Psoriasis Area and Severity Index (PASI) Score >= 125 Percent of the Baseline PASI Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in Psoriasis Area and Severity Index (PASI) Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in Psoriasis Area and Severity Index (PASI) Component Score	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. Basic characteristics of psoriatic lesions: erythema, induration, and scaling (PASI components) are scored separately for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]) according to a 5-point scale: 0 (no involvement); 1 (slight); 2 (moderate); 3 (marked); 4 (very marked). PASI component score range from 0 to 4, where higher scores indicate greater severity of psoriatic lesions.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Percentage of Participants With a Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).	Week 2, 4, 8, 12, 20, 28, 40, 52	No
Secondary	Percentage of Participants in a Physician Global Assessment (PGA) of Psoriasis Score Category	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Percentage of Participants Maintaining Psoriasis Area and Severity Index 75 (PASI75) Response After Week 16	The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline. Maintenance of PASI75 response at Week 52 among participants achieving PASI75 response at Week 16 is reported.	Week 20, 28, 40, 52	No
Secondary	Percentage of Participants Maintaining Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear'	The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear). Maintenance of PGA response at Week 52 among participants achieving PGA response at Week 16 is reported.	Week 20, 28, 40, 52	No
Secondary	Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score	The NAPSI quantifies severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Each finger nail divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). The total NAPSI score equals the sum of scores for all of the finger nails evaluated and ranges from 0 to 80. Higher scores = more severe psoriasis.	Week 8, 16, 20, 28, 40, 52	No
Secondary	Number of Affected Nails	Nail psoriasis is evaluated by the presence or absence of psoriatic manifestations on the nail matrix (pitting, leukonychia, red spots on lulunea, crumbling) and nail bed (onycholysis, splinter hemorrhages, subungual hyperkeratosis, oil drop [salmon patch dyschromia]). Total number psoriasis affected nails (presence of psoriatic manifestations on the nail matrix/nail bed) were assessed and reported.	Baseline, Week 8, 16, 20, 28, 40, 52	No
Secondary	Itch Severity Item (ISI) Score	ISI assessed severity of itch (pruritus) due to psoriasis. ISI is a single item, horizontal numeric rating scale. Participants were asked to rate "your worst itching due to psoriasis over the past 24 hours" on a numeric rating scale anchored by the terms "No itching" (0) and "Worst possible itching" (10) at the ends for post baseline time points. Baseline ISI is average of scores on 7 days prior to start of study treatment.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Dermatology Life Quality Index (DLQI) Score	The DLQI is a 10 item general dermatology questionnaire that assess health related quality of life (daily activities, personal relationships, symptoms and feelings, leisure, work and school, and treatment). The DLQI item response options are rated by the participant from 0 (not at all/not relevant) to 3 (very much) with a total score range of 0 (best) to 30 (worst); higher scores indicate poor quality of life.	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Domain Score	36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).	Week (W) 16, 28, 52	No
Secondary	Change From Baseline in 36-Item Short-Form Health Survey Version 2, Acute (SF-36): Component Summary Score	36-Item Short-Form Health Survey (SF-36) is a standardized survey evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. These 8 aspects are summarized as physical and mental health summary scores. The score range for the physical and mental health scores is 0-100 (100=highest level of functioning).	Week 16, 28, 52	No
Secondary	Work Limitation Questionnaire (WLQ)	WLQ: participant-reported 25-item scale to evaluate degree to which health problems interfere with an ability to perform job roles along 4 dimensions: Time Management scale (5 items); Physical Demands scale (6 items); Mental-Interpersonal Demands Scale (9 items); Output Demands Scale (5 items). All the scales ranged from 0 (limited none of the time) to 100 (limited all of the time). The WLQ Index score is the weighted sum of the scores from the 4 WLQ scales (total score: 0 [no loss] to 100 [complete loss of work]).	Baseline (BL), Week (W) 4, 16, 28, 52	No
Secondary	Percentage of Participants With a Patient Global Assessment (PtGA) of Psoriasis Score Category	The PtGA asks the participant to evaluate the overall cutaneous disease at that point in time on a single item, 5-point scale (0=clear [no psoriasis]; 1=almost clear; 2=mild; 3=moderate; 4=severe).	Baseline, Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Joint Pain Assessment (JPA)	The JPA assesses severity of joint pain. The JPA is a horizontal numeric rating scale. Participants were asked to "select the number that best describes any joint pain that participant may have experienced over the past 24 hours" with response options ranging from "0-no joint pain" to "10-worst possible joint pain."	Baseline, Week 4, 16, 28, 52	No
Secondary	Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response	ACR20 response: greater than or equal to (>=) 20 percent (%) improvement in tender joint count; >=20% improvement in swollen joint count; and >=20% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 2, 4, 8, 12, 20, 28, 40, 52	No
Secondary	Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response	ACR50 response: greater than or equal to (>=) 50 percent (%) improvement in tender joint count; >=50% improvement in swollen joint count; and >=50% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response	ACR70 response: greater than or equal to (>=) 70 percent (%) improvement in tender joint count; >=70% improvement in swollen joint count; and >=70% improvement in at least 3 of 5 remaining ACR core measures: participant assessment of pain; participant global assessment of disease activity; physician global assessment of disease activity; self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ]); and C-Reactive Protein (CRP).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Tender/Painful Joint Count	Sixty eight (68) joints were assessed by a rheumatologist investigator to determine the number of joints that were considered tender or painful. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Swollen Joint Count	Sixty six (66) joints were assessed for swelling by a rheumatologist investigator to determine the number of joints that were considered swelling. The response to pressure/motion on each joint was assessed with the following scale: Present/Absent/Not Done/Not Applicable (for Artificial or missing joints).	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Assessment of Arthritis Pain	Subjects assessed the severity of their arthritis pain with a 100 mm visual analog scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (the most severe pain), which corresponded to the magnitude of their pain.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Patient Global Assessment of Arthritis	Subjects answered the following question, "Considering the possible effects of the arthritis, how are you feeling today?" The subject's response was recorded with a 100 mm visual analog scale (VAS), where 0 = very well and 100 = very poorly.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Physician Global Assessment of Arthritis	The rheumatologist investigator assessed how the subject's overall arthritis appeared at the time of the visit. This was an evaluation based on the subject's disease signs, functional capacity and physical examination, and was independent of the PGA of arthritis. The rheumatologist investigator's response was recorded a 100 mm visual analog scale (VAS), where 0 = very good and 100 = very poor.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ C-Reactive Protein (CRP)	The blood samples were collected at each visit for analysis of CRP with an assay analyzed by the central laboratory.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No
Secondary	Change From Baseline in American College of Rheumatology (ACR) Component_ Health Assessment Questionnaire - Disability Index (HAQ-DI)	HAQ-DI: participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0=least difficulty and 3=extreme difficulty.	Week 2, 4, 8, 12, 16, 20, 28, 40, 52	No

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