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-naïve patients with active rheumatoid arthritis.

F. Hoffmann-La Roche Ltd.0 sites750 target enrollmentNovember 22, 2005

DrugsMabThera

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: F. Hoffmann-La Roche Ltd.
Enrollment: 750
Status: Active, not recruiting
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 22, 2005

End Date

TBD

Last Updated

12 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

F. Hoffmann-La Roche Ltd.

Eligibility Criteria

Inclusion Criteria

•1\. Able and willing to give written informed consent and comply with the requirements of the study protocol.
•2\. Patients with rheumatoid arthritis diagnosed for at least 8 weeks, but no more than 4 years, according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
•3\. Patients naïve to, and considered to be candidates for, treatment with methotrexate.
•4\. Swollen joint count (SJC) \= 8 (66 joint count), and tender joint count (TJC) \= 8 (68 joint count) at screening and baseline.
•5\. At screening CRP \= 1\.0 mg/dL (10 mg/L).
•6\. Age 18\-80 years.
•7\. Glucocorticoids \= 10 mg/day prednisolone or equivalent is permitted if stable for at least 4 weeks prior to baseline.
•8\. Use of NSAIDs is permitted if stable for at least 2 weeks prior to baseline.
•9\. For patients of reproductive potential (males and females), use of a reliable means of contraception (e.g. hormonal contraceptive, patch, intrauterine device, physical barrier) throughout study participation.
•10\. Must be willing to receive oral folate.

Exclusion Criteria

•1\. Rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis or Felty’s syndrome). Secondary Sjögren’s syndrome or secondary limited cutaneous vasculitis with RA is permitted.
•2\. Functional class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis.
•3\. History of, or current, inflammatory joint disease other than RA (including, but not limited to, gout, reactive arthritis, psoriatic arthritis, seronegative spondyloarthropathy, Lyme disease) or other systemic autoimmune disorder (including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, scleroderma, inflammatory myopathy, mixed connective tissue disease or any overlap syndrome).
•4\. Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before age 16\.
•5\. Any surgical procedure, including bone/joint surgery/synovectomy (including joint fusion or replacement) within 12 weeks prior to baseline or planned during the study.
•6\. Lack of peripheral venous access.
•7\. Pregnancy or breast feeding.
•8\. Significant and/or uncontrolled cardiac or pulmonary disease (including obstructive pulmonary disease).
•9\. Evidence of significant concomitant disease, including but not limited to, nervous system, renal, hepatic, endocrine or gastrointestinal disorders which, in the investigator’s opinion, would preclude patient participation.
•10\. Primary or secondary immunodeficiency (history of, or currently active), including known history of HIV infection.