Status:
COMPLETED
A Study to Evaluate Rituximab in Combination With Methotrexate in Methotrexate-Naive Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief 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) t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patients 18-80 years of age
- RA for ≥ 2 months;
- Receiving outpatient treatment
- Patients naive to, and considered to be candidates for, methotrexate treatment
- Exclusion criteria:
- Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
- Inflammatory joint disease other than RA, or other systemic autoimmune disorder
- Diagnosis of juvenile rheumatoid arthritis, or RA before the age of 16
- Surgery within 12 weeks of study
- Previous treatment with any approved or investigational biologic agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy
- Concurrent treatment with any biologic agent or DMARD other than methotrexate
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
755 Patients enrolled
Trial Details
Trial ID
NCT00299104
Start Date
January 1 2006
End Date
July 1 2013
Last Update
July 28 2017
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