drugset / Trial / NCT00251641

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

NCT00251641

Phase 3 Completed 868 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a Phase 3b, randomized, parallel-group, multicenter, active-controlled, open-label study of the efficacy and safety of infliximab compared with methotrexate (MTX) in the treatment of moderate to severe psoriasis in adults who were diagnosed with moderate to severe plaque-type psoriasis for at least 6 months prior to screening (subjects with concurrent psoriatic arthritis may also be enrolled).

Timeline

Start
2005-09-01
Primary completion
2008-06-01
Completion
2008-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 5 mg/kg Intravenous
Comparator Methotrexate Small molecule 15 mg Oral
Comparator Methotrexate Small molecule 20 mg Oral

Indications