NCT00243412

A Study of the Safety and Efficacy of Rituximab in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Methotrexate

A Double-Blind, Randomized, Multicenter, Phase II Study of the Safety and Efficacy of Two Rituximab Regimens in Subjects With Moderate to Severe Active Rheumatoid Arthritis Receiving Stable Doses of Methotrexate

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	folate	Minimum of 1 mg/day oral (or folinic acid 5 mg/week)
DRUG	methotrexate	15-25 mg/week oral or parenteral (10-14 mg/week if intolerant)
DRUG	methylprednisolone	100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion)
DRUG	Placebo	To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18.
DRUG	Rituximab	500 mg or 1000 mg IV\*2.

Timeline

• Start date: 2005-08-01
• Primary completion: 2009-02-01
• Completion: 2009-02-01
• First posted: 2005-10-24
• Last updated: 2011-10-07
• Results posted: 2011-10-07