Clinical trial NCT00749398: Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047)
Official title: Atlas of the Evolution of Psoriasis Lesions Under Remicade® : A Dynamic Standardized Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-09
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participation to the observational study will be proposed to Dermatology departments by the medical department of the sponsor. Subjects with moderate-to-severe psoriasis initiating infliximab in accordance with the terms of the European label will be asked to participate.

Brief summary: This is a national, multi-center, observational, prospective photographic atlas study in subjects who are treated with infliximab for moderate-to-severe psoriasis in daily clinic according to local country regulations and reimbursement.

Detailed description: Subjects will enter this study using a non-probability sampling method.

Eligibility criteria: Inclusion Criteria:

* Male or female, age \>=18 with moderate-to-severe psoriasis.
* Patient for whom the physician has decided to initiate psoriasis treatment with infliximab in accordance with the terms of the European labeling.
* Patient must demonstrate his/her willingness to participate in the observational study by signing a written consent.

Exclusion Criteria:

* Patient unable to understand and answer a self administered questionnaire.
* No specific non-inclusion criteria will be applied to eligible patients.
* Contradiction and/or Precaution listed in the Summary of Product Characteristics.

Primary outcomes:
measure: Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Dynamic Photographic PGA Score as Assessed by Two Dermatologists
timeFrame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
Secondary outcomes:
measure: Static PGA Score as Assessed by the Investigator
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Dynamic PGA Score as Assessed by the Investigator
timeFrame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
measure: Percent Body Surface Area (BSA) Involved With Psoriasis
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)
measure: Psoriasis Area and Severity Index (PASI) Score
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Nail Psoriasis Severity Index (NAPSI) Score
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Static PGA Score as Assessed by the Participant
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Dynamic PGA Score as Assessed by the Participant
timeFrame: Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)
measure: Dermatology Life Quality Index (DLQI) Score
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
measure: Number of Participants With Satisfactory Health Status
timeFrame: Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)
Other outcomes:
Locations:
Study officials:
References: