A Randomized, Double-blind, Parallel Group Study of the Safety and Effect on Clinical Outcome of Tocilizumab SC Versus Tocilizumab IV, in Combination With Traditional Disease Modifying Anti-rheumatic Drugs (DMARDs), in Patients With Moderate to Severe Active Rheumatoid Arthritis

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 24 人开始时间: 2010年12月7日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Adult participants, ≥ 18 years of age
•Rheumatoid arthritis of ≥ 6 months duration, according to American College of Rheumatology (ACR) criteria
•Swollen joint count (SJC) ≥ 4 (66 joint count), tender joint count (TJC) ≥ 4 (68 joint count) at screening and baseline
•Inadequate response to current DMARD therapy
•Permitted DMARDs must be at stable dose for ≥ 8 weeks prior to baseline
•Oral corticosteroids (≤ 10 mg/day prednisone or equivalent) and NSAIDs (up to maximum recommended dose) must be at stable dose for ≥ 4 weeks prior to baseline

•Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization
•Rheumatic autoimmune disease other than RA
•Functional class IV (ACR classification)
•Diagnosis of juvenile idiopathic arthritis (JIA) or juvenile rheumatoid arthritis (JRA) and/or RA before the age of 16
•Prior history of or current inflammatory joint disease other than RA
•Intra-articular or parenteral corticosteroids within 4 weeks prior to baseline
•Previous treatment with tocilizumab
•Active current or history of recurrent infection

发起方