A Randomized, Double-blind, Parallel-group, Study to Evaluate the Efficacy, Safety and PK/PD of Ocrelizumab in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Therapy

NCT00779220 Phase 2 TERMINATED

This study will evaluate the efficacy, safety and PK/PD of ocrelizumab at each dose in combination with methotrexate（MTX）in patients with active rheumatoid arthritis (RA). The data from this study will also be compared with those from a clinical study of ocrelizumab in patients with active RA that was conducted in the U.S.

Details

Lead sponsor	Chugai Pharmaceutical
Phase	Phase 2
Status	TERMINATED
Enrolment	152
Start date	2008-10
Completion	2015-03

Conditions

• Rheumatoid Arthritis

Interventions

• placebo
• methotrexate
• ocrelizumabu 50mg
• ocrelizumabu 200mg
• ocrelizumab 500mg

Primary outcomes

• Percentage of patients with ACR20 response. — week 24

Countries

Japan