A Study of Ocrelizumab in Participants With Moderate to Severe Rheumatoid Arthritis (RA)

• Status: Terminated
• Trial end date: 2013-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is in two parts and will evaluate the safety, tolerability and efficacy of escalating single intravenous (IV) doses of ocrelizumab compared with placebo in combination with methotrexate in participants with moderate to severe RA. Part 1 is the dose-escalation study, at one of the following dose levels of ocrelizumab [400, 1000, 1500, and 2000 milligrams (mg)]. In Part 2, participants will be randomized to explore tolerability and efficacy of doses which have been shown to be tolerated in Part 1.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ocrelizumab

Criteria

Inclusion Criteria:

• Moderate to severe RA for at least 6 months

• Positive serum rheumatoid factor (>/= 20 international units per milliliter)

• Current treatment with RA on an outpatient basis

• Treatment failure with one disease modifying anti-rheumatic drug (DMARD) or biologic, but have not failed more than six of these agents including methotrexate

• Current treatment with methotrexate for at least 12 weeks, at a stable dose

• Use of highly effective contraception.

Exclusion Criteria:

• Rheumatic autoimmune disease or inflammatory joint disease, other than RA

• Concurrent treatment with any disease-modifying anti-rheumatic drug (DMARD) (other than methotrexate) or any anti-tumor necrosis factor (TNF) -alfa or other biologic therapy

• Treatment with any other investigational drug within 4 weeks of screening

• Previous treatment with cell-depleting therapies, IV gamma-globulin, intra-articular or parenteral corticosteroids, and receipt of live/attenuated vaccine prior to screening

• Previous treatment with rituximab or any other anti-cluster of differentiation 20 (CD20) agent

• History of severe allergic or anaphylactic reactions to humanized monoclonal antibodies

• Known active bacterial, viral or fungal infections

• History of active tuberculosis and primary or secondary immunodeficiency

• History of concomitant diseases such as cardiovascular disease, nervous system, pulmonary disease, renal, hepatic, endocrine or gastrointestinal disorders

• Pregnancy or lactation.