Participants from an ongoing observational study (P05319) who have a limited (adequate but less than optimal) response to infliximab will be randomized to either increase the frequency of infliximab infusions from every 8 weeks to every 6 weeks, or to add weekly methotrexate to their current treatment plan. While receiving infliximab study treatment(s), patients in this study will attend regularly scheduled office visits for various clinical tests for safety and effectiveness evaluations.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
39
Infliximab 5 mg/kg body weight intravenous infusion given every 6 weeks
Infliximab 5 mg/kg body weight intravenous infusion (given every 8 weeks) plus methotrexate 7.5 mg orally (once weekly)
Number of Participants With A Psoriasis Area and Sensitivity Index (PASI)-75 Response at Week 28
The Psoriasis Area and Sensitivity Index (PASI) is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-75 response indicates the number of participants achieving a 75% reduction in PASI score compared to baseline.
Time frame: Baseline, Week 28
Number of Participants With A PASI-50 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.The PASI-50 response indicates the number of participants achieving a 50% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Number of Participants With A PASI-90 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-90 response indicates the number of participants achieving a 90% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Number of Participants With A PASI-100 Response at Week 28
The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity. The PASI-100 response indicates the number of participants achieving a 100% reduction compared to baseline in PASI score.
Time frame: Baseline, Week 28
Change From Baseline in Mean Participant Raw PASI Scores at Week 28
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The PASI score is a measure of the average redness, thickness, and scaliness of psoriasis lesions. Each lesion is graded on a 0-4 scale, weighted by the area of involvement, with increasing scores indicating increasing severity.
Time frame: Baseline, Week 28
Dermatology Life Quality Index (DLQI) at Week 28
The DLQI is a 10-item questionnaire. Scores range from 0-10 with 0 indicating high quality of life and 10 indicating poor quality of life.
Time frame: Week 28
Euro-Qol 5 Dimension (EQ-5D) Change From Baseline at Week 28
The EQ-5D is a descriptive system comprised of the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Participants are asked to indicate his/her health state by selecting the most appropriate statement in each of the 5 dimensions. This selection results in a 1-digit number expressing the level selected for that dimension. The digits for 5 dimensions can be combined in a 5-digit number describing the participant's health state. The numerals 1-5 have no arithmetic properties and should not be used as a cardinal score.
Time frame: Baseline, Week 28