Study of Adalimumab (HUMIRA®) in Patients With Moderate to Severe Psoriasis (PS) in Spain (PROMISE)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

547 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-09-30

Brief Summary

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The purpose of this study is to evaluate the effectiveness and safety of adalimumab as used in routine clinical practice in adult patients with moderate to severe chronic plaque psoriasis in Spain.

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Detailed Description

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PROMISE is a 2 year post-authorization study of patients taking adalimumab for Psoriasis. Patients who volunteer to participate will be asked to provide information about their medical history and experiences with adalimumab. No study specific testing will be performed. Patients will be asked to provide data on their experiences with adalimumab approximately every 6 months, or as determined by the study doctor. No drug will be provided as a result of participation in the registry. All treatment decisions are independent of participation in the registry. A total of 547 subjects were enrolled: 532 in the ITT population were analyzed for efficacy (excluding 15 for lack of follow-up visits (n=8), non-fulfillment of the criteria of moderate to severe PS (n=6) and failure to initiate treatment at the baseline visit (n=1)); 542 were analyzed for safety (excluding 5 due to lack of evaluable safety data).

Conditions

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Moderate-to-severe Chronic Plaque Psoriasis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-severe chronic plaque psoriasis

Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patient 18 years of age or older.
* Patient diagnosed with moderate to severe chronic plaque PS beginning treatment with adalimumab in accordance with the authorized conditions of use.
* Patient gives informed consent in writing.

Exclusion Criteria

* Patients who cannot be treated in accordance with the local product label
* Patient participating or going to participate in a clinical trial during the study follow-up
* Patient with difficulties for adequately reading, understanding and completing a questionnaire

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No