NCT00299104

A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 755 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III, randomized, controlled, double-blind, parallel group, international study in approximately 750 patients with active Rheumatoid Arthritis (RA) who are naive to Methotrexate (MTX) therapy. Rheumatoid Factor (RF)-positive and RF-negative patients will be enrolled and will be allocated equally between 3 treatment arms.

Conditions

• Rheumatoid Arthritis

Interventions

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

Timeline

• Start date: 2006-01-01
• Primary completion: 2008-09-01
• Completion: 2013-07-01
• First posted: 2006-03-06
• Last updated: 2017-07-28
• Results posted: 2011-08-10