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Clinical Trials associated with Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)评估重组人白细胞介素-1受体拮抗剂(rhIL-1Ra)治疗成人中重度活动性类风湿关节炎的有效性和安全性的III期临床试验
[Translation] A phase III clinical trial to evaluate the efficacy and safety of recombinant human interleukin-1 receptor antagonist (rhIL-1Ra) in the treatment of moderately to severely active rheumatoid arthritis in adults
主要目的:评价重组人白细胞介素-1受体拮抗剂注射液(rhIL-1Ra)治疗经≥1种缓解病情抗风湿药物(DMARDs)治疗失败的中重度活动性类风湿关节炎(RA)的有效性。 次要目的:评价rhIL-1Ra治疗经≥1种DMARDs治疗失败的中重度活动性RA的安全性和免疫原性。
[Translation] Primary objective: To evaluate the efficacy of recombinant human interleukin-1 receptor antagonist injection (rhIL-1Ra) in the treatment of moderately to severely active rheumatoid arthritis (RA) that has failed to respond to ≥1 disease-modifying antirheumatic drug (DMARDs). Secondary objective: To evaluate the safety and immunogenicity of rhIL-1Ra in the treatment of moderately to severely active RA that has failed to respond to ≥1 DMARDs.
100 Clinical Results associated with Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)
100 Translational Medicine associated with Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)
100 Patents (Medical) associated with Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)
100 Deals associated with Anakinra biosimilar(Shanghai Biomabs Pharmaceuticals Co., Ltd.)