drugset / Trial / NCT00202852

A Placebo-Controlled, Double-Blinded, Randomized Trial of Remicade in Korean Patients With Rheumatoid Arthritis Despite Methotrexate (Study P04280)(COMPLETED)

NCT00202852

Phase 3 Completed 143 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupDouble-blindTreatment

Summary

Prior to the first infusion, patients will be randomized into one of two groups (placebo or infliximab). All patients will continue to receive the same does of methotrexate (MTX) during the study as received prior to the study. The objective of the study is to evaluate the efficacy and safety result of infliximab with Korean patients in reducing clinical signs and symptoms of rheumatoid arthritis (RA) at 30 weeks following the onset of treatment and to review whether the result is comparable to the result of the ATTRACT trial.

Timeline

Start
2005-06-01
Primary completion
2006-03-01
Completion
2006-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Infliximab Monoclonal antibody 3 mg/kg Intravenous
Background Methotrexate Small molecule 12.5 mg Oral
Background Methotrexate Small molecule 20 mg Oral

Indications