MIRACLE (Methotrexate inadequate response patient with Rheumatoid Arthritis treated by Adalimumab in combination with Low-dose Methotrexate) Study - MIRACLE Study

Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine0 个研究点目标入组 300 人开始时间: 2017年12月27日最近更新: 2023年10月17日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 300

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

This study demonstrated that in patients with rheumatoid arthritis with inadequate response to methotrexate, the efficacy of adalimumab with reduced dose of concomitant methotrexate was not inferior to that with maximum tolerable dose of methotrexate. There was no significant difference about HAQ remission rate and structural remission rate between the two groups. The incidence of AEs was numerically lower in reduced dose group than in maximum tolerable dose group.

研究设计

研究类型: Interventional

入排标准

年龄范围: 18years-old 至 ot applicable（—）
性别: All

入选标准

未提供

排除标准

•1) Patients who currently have a malignant tumor, except for non-melanoma forms of skin cancer limited within epidermis, and uterine cervix cancer limited within epidermis 2) Patients who have serious infections such as sepsis 3) Patients who have active tuberculosis 4) Patients who have a history or current complication of demyelinating disease such as multiple sclerosis 5) Patients who have congestive heart failure 6) Pregnant female, or female who intend to conceive during the study period 7) Patients who have bone marrow depression and whom investigator considered ineligible 8) Patients who have chronic liver disease and whom investigator considered ineligible, and who is positive for HBs antigen 9) Patients who have nephropathy and whom investigator considered ineligible 10) Lactating female 11) Patients who have pleural effusion or ascites 12) Patients with a known hypersensitivity to MTX or ADA 13) Patients otherwise whom principal investigator/sub-investigator considered medically ineligible to participate in the study

研究者

发起方

Keio University School of Medicine Division of Rheumatology, Department of Internal Medicine

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