A Randomized, Phase 3, Controlled, Double-Blind, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Rituximab in Combination With Methotrexate (MTX) Compared to MTX Alone, in Methotrexate-Naive Patients With Active Rheumatoid Arthritis

F. HOFFMANN-LA ROCHE LTD.,0 sites35 target enrollmentMay 10, 2007

Conditions-M069 M069

Overview

No summary available.

Registry

who.int

Start Date

May 10, 2007

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•1\. Be willing to grant written informed consent and comply with the requirements of the study protocol.
•2\. Patients with active rheumatoid arthritis diagnosed for at least 8 weeks but not more than 4 years.
•3\. Virgin patients to, and considered to be candidates for, treatment with methotrexate.
•4\. Swollen joint count (SJC) ≥ 8, and Painful joint count (TJC) ≥ 8\.
•5\. CRP ≥12 mg / dL.
•6\. From 18 to 80 years of age.
•7\. Glucocorticoids ≤ 10 mg / day of prednisolone or equivalent allowed if it is stable at least 4 weeks before the baseline visit.
•8\. The use of NSAIDs is allowed if it is stable for at least 2 weeks before the baseline visit.
•9\. For patients of reproductive age (men and women), use reliable contraceptive methods throughout their participation in the study.
•10\. They must agree to receive oral folate.

•1\. Autoimmune rheumatic disease different from RA, or with significant systemic manifestations.
•2\. Functional class IV.
•3\. History of inflammatory joint disease different from RA.
•4\. Diagnosis of juvenile idiopathic arthritis before the age of 16 years.
•5\. Any surgical procedure.
•6\. Lack of peripheral venous access.
•7\. Pregnancy or breastfeeding, maternal.
•8\. Significant pulmonary or cardiac disease.
•9\. Evidence of significant uncontrolled concomitant disease.
•10\. Primary or secondary immunodeficiency.

Not specified