Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

Moderate to Severe Psoriasis Clinical Trial

Official title:

Observational Study; Clinical Effectiveness and Impact on Health-related Quality of Life in Peruvian Patients With Psoriasis After 16 Weeks of Adalimumab Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01156532
• Other study ID #: P12-261
• Status: Terminated
• Phase: N/A
• First received: July 1, 2010
• Last updated: August 8, 2014
• Start date: November 2010
• Est. completion date: August 2013

Study information

• Verified date: August 2014
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Ethics Committee
• Study type: Observational

Clinical Trial Summary

Adalimumab has recently been authorized for active psoriasis in Peru and local experience is very low. The aim of this study is to obtain Peruvian data of clinical effectiveness and impact on health-related quality of life with the use of adalimumab in participants with chronic plaque psoriasis complying with the dosing and monitoring recommendations of the local approved label.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) = 10 and body surface area = 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate

• Participant is capable of and willing to give written informed consent and to comply with the requirements of the study protocol

Exclusion Criteria:

• Participants should not be enrolled if they cannot be treated in accordance with the local product label

• Participants enrolled into another study or clinical trial

• History of hepatitis B infection

• History of neurologic symptoms suggestive of central nervous system demyelinating disease

• History of cancer or lymphoproliferative disease (other than successfully treated non-melanoma skin cancer or localized carcinoma in situ of the cervix)

• Active tuberculosis infection before initiating adalimumab treatment or latent tuberculosis infection not able to take complete prophylactic treatment

• Pregnant or lactating female, demonstrated by a pregnancy test before entering the study and willing to use a contraceptive method

• Use of another anti-tumoral necrosis factor previously

• History of congestive heart failure

• Any other condition that according to the criteria of the participating investigator represents an obstacle for study conduction and/or subjects participants to an unacceptable risk

• Participants with active infection including chronic or localized infections until infections are controlled

• History of sensitivity to latex

• Participants who will receive concomitant phototherapy and systemic therapy during adalimumab therapy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Moderate to Severe Psoriasis
• Psoriasis

Locations

Country	Name	City	State
Peru	Site Reference ID/Investigator# 35783	Lima
Peru	Site Reference ID/Investigator# 56700	Lima
Peru	Site Reference ID/Investigator# 43147	Trujillo

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Reaching a Psoriasis Area and Severity Index 75 (PASI-75) Response	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). PASI-75 responders are the participants who achieved at least a 75% reduction (improvement) from baseline in PASI score at Week 16. The mean PASI improvement was calculated using a linear regression model.	Baseline to Week 16	No
Primary	Percentage of Participants Reaching a Minimal Important Difference (MID) in the Dermatology Life Quality Index (DLQI) Score	Dermatology Life Quality Index (DLQI) score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. MID for the DLQI was defined as a score decrease from baseline of 2.3 to 5. The mean DLQI improvement was calculated using a linear regression model.	Baseline to Week 16	No
Secondary	European Quality of Life 5 Dimensions (EQ-5D) Index Score at Baseline and Week 16	EQ-5D is a self-reported health outcome which measures mobility, self-care, usual activities, pain discomfort, anxiety, and depression. An overall score is derived that measures from -0.59 (worst) to +1 (best). Improvement was defined as a mean score increase of at least 0.2.	Baseline, Week 16	No
Secondary	Number of Participants With Serious Adverse Events (SAEs)	An adverse event was considered an SAE if it met any of the following criteria: death of the participant; life-threatening event; hospitalization; prolongation of hospitalization; congenital anomaly; persistent or significant disability/incapacity; an important medical event requiring medical or surgical intervention to prevent serious outcome; spontaneous or elective abortion. SAEs included the occurrence of tuberculosis, opportunistic infection, and malignancy.	From the time of informed consent until 70 days (5 half-lives) after the last dose of study drug (treatment was 16 weeks).	Yes
Secondary	Adherence to Adalimumab Treatment	Adherence was measured by how many times a participant had a discontinuation (i.e., missed a study dose) during the 16 weeks of treatment.	up to 16 weeks	No
Secondary	Mean Psoriasis Area and Severity Index (PASI) Score Over Time	PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (plaque thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The score ranges from 0 (no psoriasis) to 72 (very severe psoriasis). The mean PASI improvement was calculated using a linear regression model.	Baseline, Week 4, Week 8, Week 16	No
Secondary	Mean Dermatology Life Quality Index (DLQI) Score Over Time	DLQI score is a participant-reported outcome consisting of a set of 10 questions regarding the degree to which the participant's skin has affected certain behaviors and quality of life over the last week. Responses to each are: very much (score of 3), a lot, a little, or not at all (score of 0). The DLQI score ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The mean DLQI improvement was calculated using a linear regression model.	Baseline, Week 4, Week 8, Week 16	No

External Links

•   Link