A randomized, double-blind, parallel-group study of the reduction of signs and symptoms during treatment with tocilizumab versus adalimumab, both in combination with MTX, in patients with moderate to severe active rheumatoid arthritis and an inadequate response to treatment with only one TNF inhibitor. - MA25522 Act First

Roche Nederland B.V.0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

暂无简介。

•1) Able and willing to give written informed consent
•2) Rheumatoid arthritis of at least 6 months duration diagnosed according to the ACR criteria
•3) Age 18 years or older
•4) Have experienced an inadequate response due to inefficacy of treatment with only one approved anti-TNF agent other than adalimumab
•5) Have received MTX for at least 12 weeks immediately prior to baseline
•6) DAS28 score at baseline greater than 3.2
•7) Females of child-bearing potential may participate in this trial only if using reliable means of contraception
•8)Receiving treatment on an outpatient basis

•1) Major surgery within 8 weeks prior to screening or planned surgery within 6 months following randomization
•2) Rheumatic autoimmune disease other than RA, including systemic lupus erythematosus (SLE), mixed connective tissuedisease (MCTD), scleroderma, polymyositis, or significant systemic involvement secondary to RA (e.g. vasculitis, pulmonary fibrosis or Felty's syndrome)
•3) Functional class IV as defined by the ACR criteria for Classification of Functional Status in Rheumatoid Arthritis
•4) Prior history of current inflammatory joint disease other than RA
•5) History of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies including tocilizumab
•6) Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disease
•7) Uncontrolled disease status, such as asthma, psoriasis or inflammatory bowel disease
•8) Active TB requiring treatment within the previous 3 years.

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