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Ocrelizumab Single vs Dual Infusion vs Placebo in Methotrexate-Inadequate Response Rheumatoid Arthritis
2007-005759-41Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2008
- Countries
- 1
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies → Antibody-Based Therapeutics
- Drugs
- ocrelizumab
- Conditions
- rheumatoid arthritis (RA)
01
Overview
Phase 3, randomised, double-blind trial of ocrelizumab in rheumatoid arthritis (RA) (3 arms), sponsored by Roche. Primary endpoint: ACR20 response at 24 weeks. Started Feb 2008; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Single infusion ocrelizumab
Patients receive a single infusion regimen of ocrelizumab plus background methotrexate.
Dual infusion ocrelizumab
Patients receive a dual infusion regimen of ocrelizumab plus background methotrexate.
Placebo
Patients receive placebo infusions plus background methotrexate.
03
Who it enrols
Adult patients with active rheumatoid arthritis and inadequate response to methotrexate therapy; healthy volunteers are not included. Active infection and pregnancy are excluded, and contraception is required.
04
Endpoints
Primary
ACR20 response at 24 weeks
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