Status:
TERMINATED
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Lead Sponsor:
Genentech, Inc.
Collaborating Sponsors:
Roche Pharma AG
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in combination with methotrexate in patients with active rheumatoid arthritis who have had an inadequate respons...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Adult patients, ≥18 years of age
- Rheumatoid arthritis for ≥ 3 months
- Inadequate clinical response to methotrexate at a dose of 7.5-25mg/week for ≥ 12 weeks
- Exclusion criteria:
- Rheumatic autoimmune disease or inflammatory joint disease, other than RA
- Prior receipt of any biologic therapy for RA
- Concurrent treatment with any DMARD (other than methotrexate)
Exclusion
Key Trial Info
Start Date :
December 27 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 22 2015
Estimated Enrollment :
1015 Patients enrolled
Trial Details
Trial ID
NCT00406419
Start Date
December 27 2006
End Date
April 22 2015
Last Update
November 27 2020
Active Locations (1)
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1
Trial Information Support Line
South San Francisco, California, United States, 94080