A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
A Randomized, Double-Blind, Parallel Group, International Study to Evaluate the Safety and Efficacy of Ocrelizumab Compared to Placebo in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Anti-TNF-α Therapy
This study will evaluate the efficacy and safety of ocrelizumab, compared with placebo, in patients with active rheumatoid arthritis who have an inadequate response to at least one anti-TNF-alpha therapy. 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 stable doses of either concomitant methotrexate (7.5-25mg/week) or leflunomide (10-20mg po daily) and may receive additional DMARDs. The treatment period is planned for 48 weeks (until primary analysis) and then participants will enter the open label phase until the drug is commercialized. Target sample size is 1000.
Inclusion Criteria:
Exclusion Criteria:
Tucson, Arizona 85724, United States
Los Alamitos, California 90720, United States
Colorado Springs, Colorado 80920, United States
Camden, Connecticut 06510, United States
Springfield, Missouri 65807, United States
St Louis, Missouri 63131, United States
San Antonio, Texas 78217, United States
Onalaska, Wisconsin 54605, United States
Curtiba, Paraná 80030-110, Brazil
Rio de Janeiro, Rio de Janeiro 21941-590, Brazil
Edmonton, Alberta T6G 2S2, Canada
Freiburg im Breisgau, 79106, Germany
Giessen, 35392, Germany
Hanover, 30625, Germany
Heidelberg, 69121, Germany
München, 80336, Germany
Würzburg, 97080, Germany
Debrecen, 4032, Hungary
Beer Yaakov, 6093000, Israel
Fukuoka, 807-8555, Japan
Fukuoka, 810-8563, Japan
Hokkaido, 060-8648, Japan
Amsterdam, 1105 AZ, Netherlands
Szczecin, 71-252, Poland
Ljubljana, 1000, Slovenia
A Coruña, LA Coruña 15006, Spain
Oviedo, Principality of Asturias 33006, Spain