At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 478 enrolled
Drug / intervention
Methotrexate +2 moredrug
Likely dose
Etanercept 1 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Adding Methotrexate to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
In Brief
A Phase 3 clinical trial evaluating Methotrexate, Etanercept, and 1 other intervention for Psoriasis. Completed, enrolled 478 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPsoriasis
Countries--
CollaboratorsImmunex Corporation
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 2009
Enrollment StartNov 2009
Primary CompletionDec 2010
Study CompletionFeb 2011
TodayJul 2026
First PostedOct 26, 2009
Enrollment StartNov 1, 2009
Primary CompletionDec 1, 2010
Study CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 16.7 years ago
Interventions
Methotrexatedrug
Methotrexate tablets over-encapsulated for blinding
Etanerceptdrug
1 mL for subcutaneous injection
Placebodrug
Matching placebo to methotrexate capsules