Conditions: Psoriasis
Keywords: Etanercept Methotrexate Psoriasis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 478
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the efficacy of adding methotrexate to etanercept compared with etanercept monotherapy as measured by the percentage of participants achieving a 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI 75) at Week 24.

Detailed description:

Arms:
arm 1: Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period. arm 2: Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.

Interventions: intervention 1: Methotrexate intervention 2: Etanercept intervention 3: Placebo
Intervention descriptions: intervention 1: Methotrexate tablets over-encapsulated for blinding intervention 2: 1 mL for subcutaneous injection intervention 3: Matching placebo to methotrexate capsules

Protocol document: