drugset / Trial / NCT00207714

An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis

NCT00207714

Phase 2 Completed 172 enrolled Centocor, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week intervals in subjects with active RA despite MTX therapy.

Timeline

Start
2003-11
Primary completion
2005-02
Completion
2006-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Golimumab Monoclonal antibody 50 mg Subcutaneous
Subject Golimumab Monoclonal antibody 100 mg Subcutaneous
Background Infliximab Monoclonal antibody 10 mg/ml Subcutaneous
Background Methotrexate Small molecule 10 mg/ml Subcutaneous

Indications