NCT00074438

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 465 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	methotrexate	Oral or parenteral repeating dose
DRUG	rituximab	Intravenous repeating dose
DRUG	corticosteroids	Intravenous repeating dose
DRUG	placebo	Intravenous repeating dose

Timeline

• Start date: 2003-06-01
• Primary completion: 2004-09-01
• Completion: 2011-07-01
• First posted: 2003-12-15
• Last updated: 2013-05-09