The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED)

PHASE3CompletedINTERVENTIONAL
Enrollment

868

Participants

Timeline

Start Date

September 1, 2005

Primary Completion Date

June 1, 2008

Study Completion Date

June 1, 2008

Conditions
Psoriasis
Interventions
DRUG

infliximab

The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.

DRUG

methotrexate

Methotrexate will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a \<25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00251641 - The Effects of Infliximab Versus Methotrexate in the Treatment of Moderate to Severe Psoriasis (Study P04271AM2)(COMPLETED) | Biotech Hunter | Biotech Hunter