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 个研究点目标入组 750 人2006年2月27日

适应症Rheumatoid arthritis MedDRA version: 9.1Level: LLTClassification code 10039073Term: Rheumatoid arthritis

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Rheumatoid arthritis
发起方: F. Hoffmann-La Roche Ltd.
入组人数: 750
状态: 进行中（未招募）
最后更新: 12年前

概览研究者入排标准结局指标相似试验

概览

简要总结

暂无简介。

注册库

who.int

开始日期

2006年2月27日

结束日期

待定

最后更新

12年前

研究类型

Interventional clinical trial of medicinal product

性别

All

研究者

发起方

F. Hoffmann-La Roche Ltd.

入排标准

入选标准

•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, prior to baseline, 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) both at screening and baseline.
•5\. At screening CRP \= 1\.0 mg/dL (10 mg/L).
•6\. Miniumum age 18
•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.

排除标准

•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.