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.

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 700 人开始时间: 2011年3月2日最近更新: 2012年11月19日

适应症

试验速览

暂无简介。

•- Adult patients, >/= 18 years of age
•- Rheumatoid arthritis of >/= 6 months duration (according to ACR criteria)
•- Inadequate response due to inefficacy of treatment (at least 3 months) with only one approved TNF-agent other than adalimumab. Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
•- On methotrexate treatment for >/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
•- Disease Activity Score (DAS28) >3.2 at baseline
•- Oral corticosteroids (/=6 weeks prior to baseline
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 539
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 161

•- Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
•- Rheumatic autoimmune disease other than rheumatoid arthritis
•- Prior history of or current inflammatory joint disease other than rheumatoid arthritis
•- Functional class IV (ACR criteria)
•- History of severe allergic reaction to human, humanized or murine monoclonal antibodies
•- Known active current or history of recurrent infection (including TB)
•- Primary or secondary immunodeficiency (history of or currently active)
•- Body weight >150 kg
•- Previous treatment with any cell-depleting therapies
•- Previous treatment with tocilizumab
•- Intra-articular or parenteral corticosteroids within 6 weeks prior to baseline

发起方