Status:
COMPLETED
A Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate Compared to Methotrexate Alone in 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 study evaluated the efficacy and safety of rituximab in patients with active rheumatoid arthritis (RA).
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patients 18-80 years of age.
- Rheumatoid arthritis (RA) for ≥ 6 months, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
- Receiving outpatient treatment for RA.
- Swollen joint count (SJC) ≥ 8 (66 joint count), and tender joint count (TJC) ≥ 8 (68 joint count) at screening and baseline.
- At screening, either
- C-reactive protein (CRP) ≥ 0.6 mg/dL (6 mg/L), or
- Erythrocyte sedimentation rate (ESR) ≥ 28 mm/hour.
- Inadequate response to methotrexate, having received and tolerated at a dose of 10-25 mg/week it for ≥ 12 weeks.
- 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 or planned within 24 weeks of randomization.
- Previous treatment with any approved or investigational biological agent for RA, an anti-alpha4-integrin antibody or co-stimulation modulator, or cell-depleting therapy.
Exclusion
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
511 Patients enrolled
Trial Details
Trial ID
NCT00299130
Start Date
October 1 2005
End Date
July 1 2013
Last Update
April 17 2017
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