A Study to Evaluate the Safety of Escalating Doses of Ocrelizumab in Subjects With Rheumatoid Arthritis
Completed
Genentech, Inc.
Phase 1/Phase 2
2004-02-01
This is a randomized, placebo-controlled, multicenter, blinded Phase I/II, investigator and
subject-blinded study of the safety of escalating doses of ocrelizumab in combination with
MTX in subjects with moderate to severe RA
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Terminated
Roche Pharma AG
Phase 3
2006-12-27
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 response to methotrexate. Patients will be randomized to receive placebo, 200mg of
intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of
i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -
25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment
is 1-2 years. Target sample size is 1000.
A Study of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Continuing Methotrexate Treatment (STAGE)
Terminated
Genentech, Inc.
Phase 3
2006-12-27
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 response to methotrexate. Patients will be randomized to receive placebo, 200mg of
intravenous ocrelizumab or 500mg of i.v. ocrelizumab on Days 1 and 15. A repeat course of
i.v. treatment will be administered at Weeks 24 and 26. All patients will receive 7.5mg -
25mg/week concomitant methotrexate at a stable dose. The anticipated time on study treatment
is 1-2 years. Target sample size is 1000.
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