NCT00299130

A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in Patients With Active Rheumatoid Arthritis

A Randomized, Placebo Controlled, Double-blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate, Compared to Methotrexate Monotherapy, in Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 511 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	Folate	A stable dose, ≥ 5 mg/week given as either a single dose or as a divided weekly dose, orally.
DRUG	Methotrexate	A stable dose of between 10-25 mg/week, oral or parenteral, as prescribed by the treating physician.
DRUG	Methylprednisolone	Intravenous infusion
DRUG	Placebo	Placebo to rituximab intravenous infusion
DRUG	Rituximab	Intravenous infusion

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-06-01
• Completion: 2013-07-01
• First posted: 2006-03-06
• Last updated: 2017-04-17
• Results posted: 2013-06-28