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Therapeutic Areas: Rheumatology | Musculoskeletal
Disease Category: Rheumatoid Arthritis
Trial Information
A randomized, double-blind study of the effect of ocrelizumab in combination with methotrexate, compared to methotrexate alone, on the treatment response in methotrexate-naive patients with active rheumatoid arthritis.
This study will evaluate the efficacy and safety of ocrelizumab,
compared with placebo, in combination with methotrexate in patients
with active rheumatoid arthritis who are naive to methotrexate.
Patients will be randomized to receive placebo, ocrelizumab 200mg
i.v. or ocrelizumab 500mg i.v. on days 1 and 15. Repeat courses of
i.v. treatment will be administered at weeks 24, 52 and 76.All
patients will receive concomitant methotrexate (7.5 mg escalating
to 20mg p.o. weekly). The anticipated time on study treatment is 2+
years, and the target sample size is 500+ individuals.In the US
this study is sponsored/managed by Genentech, under protocol no.
ACT3984g.
Patient Inclusion Criteria:
- adult patients, = 18 years of age;
- rheumatoid arthritis for 3 months-5 years;
- naive to methotrexate;
- if receiving steroids or NSAIDs, must be on a stable dose for 4
weeks prior to baseline.
Patient 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.
Lynn Spencer, RN
The Osteoporosis & Clinical Trials Center
921 Seton Drive
Cumberland, MD 21502
Phone: 1-301-724-4337 ext 3
Fax: 1-301-724-3276
EMail: lspencer@rheumdocs.com
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If you would like to learn more about participating in this study, please send an e-mail message using the form below.
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