Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047)

NCT00749398 | Completed Results

• 1 other identifier: P05047
• Study Type: observational
• Target: 133
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists

  Digital pictures of each participant's whole body were taken at each visit. Static PGA was assessed by two dermatologists on the basis of these pictures at a single point in time. The mean of the two readings from the dermatologists was used. Static PGA score ranged from 0 (no psoriasis) to 5 (extreme psoriasis). The higher the number, the more severe the psoriasis was.

  Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)

• Dynamic Photographic PGA Score as Assessed by Two Dermatologists

  The dynamic PGA score resulted from the comparison of two sets of pictures/visits. The dynamic PGA was scored twice, at the middle and at the end of the observation period (comparison between picture sets of Week 0 (Visit 1) and Week 14 (Visit 4) visits and comparison between picture sets of Week 0 (Visit 1) and Week 30 (Visit 6) visits. Dynamic PGA was assessed by two dermatologists and the mean of the two readings was used. Clinical improvement was measured with a 10 centimeter (cm)-visual analogue scale (VAS) ranging from 0 (no improvement) to 10 (disappearance of lesions).

  Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)

Secondary Outcomes (9)

• Static PGA Score as Assessed by the Investigator

  Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)

• Dynamic PGA Score as Assessed by the Investigator

  Week 0 (Visit 1), Week 14 (Visit 4), Week 30 (Visit 6)

• Percent Body Surface Area (BSA) Involved With Psoriasis

  Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5),Week 30 (Visit 6)

• Psoriasis Area and Severity Index (PASI) Score

  Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)

• Nail Psoriasis Severity Index (NAPSI) Score

  Week 0 (Visit 1), Week 2 (Visit 2), Week 6 (Visit 3), Week 14 (Visit 4), Week 22 (Visit 5), Week 30 (Visit 6)

Study Arms (1)

Infliximab

Subjects with moderate-to-severe psoriasis who are treated with infliximab in daily clinics according to local country regulations and reimbursements.

Biological: Infliximab

Interventions

Infliximab BIOLOGICAL

According to local country regulations.

Also known as: Remicade, SCH 215596

Infliximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patient unable to understand and answer a self administered questionnaire.
• Contradiction and/or Precaution listed in the Summary of Product Characteristics.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2008
• First Posted: September 9, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 28, 2015
• Results First Posted: October 4, 2011

Record last verified: 2015-07