N/A
Completed N=124
Photographic Library of Moderate to Severe Psoriasis Subjects Treated With Infliximab (Study P05047)
Source: ClinicalTrials.gov NCT00749398 ↗Enrolled (actual)
124
Serious AEs
12.8%
Results posted
Oct 2011
Primary outcomePrimary: Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists — 3.15; 2.77; 2.08; 1.76 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Static Photographic Physician Global Assessment (PGA) Score as Assessed by Two Dermatologists |
3.15; 2.77; 2.08; 1.76; 1.49; 1.72 | — |
| PRIMARY Dynamic Photographic PGA Score as Assessed by Two Dermatologists |
7.05; 7.7 | — |
| SECONDARY Static PGA Score as Assessed by the Investigator |
3.84; 3.21; 2.27; 1.92; 1.72; 2.03 | — |
| SECONDARY Dynamic PGA Score as Assessed by the Investigator |
7.27; 7.28 | — |
| SECONDARY Percent Body Surface Area (BSA) Involved With Psoriasis |
42.33; 34.86; 22.95; 16.86; 10.84; 14.12 | — |
| SECONDARY Psoriasis Area and Severity Index (PASI) Score |
21.92; 12.95; 8.00; 6.38; 5.33; 7.17 | — |
| SECONDARY Nail Psoriasis Severity Index (NAPSI) Score |
28.74; 27.08; 22.17; 18.64; 17.53; 15.67 | — |
| SECONDARY Static PGA Score as Assessed by the Participant |
4.02; 3.35; 2.5; 2.24; 1.9; 2.2 | — |
| SECONDARY Dynamic PGA Score as Assessed by the Participant |
6.91; 6.56 | — |
| SECONDARY Dermatology Life Quality Index (DLQI) Score |
13.55; 8.75; 5.46; 4.89; 4.18; 5.39 | — |
| SECONDARY Number of Participants With Satisfactory Health Status |
9; 42; 61; 61; 63; 46 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00749398). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.