JPRN-UMIN000006702已完成未知
A parallel group, randomized clinical trial on the efficacy and safety of intensive treatment strategy with MTX as the anchor-drug in patients with active early rheumatoid Arthritis - An intensive treatment strategy in patients with active early RA
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 290
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •A patient who has any of the following will be excluded from the study. 1.When a patient refuses to give or withdraws his or her consent. 2.A patient who with concurrent other inflammatory joint diseases (ankylosing spondylitis, psoriatic arthritis, reactive arthritis, SLE, systemic sclerosis and mixed connective tissue disease), or history of these diseases. Sjogren syndrome is not included in these diseases. 3.When a patient has contraindications for MTX or tacrolimus. 4.When a patient has an active infectious disease. 5.A patient who is positive for HBs antigen or HBV DNA is excluded unless he/she receive nucleotide analogue and becomes negative for HBV DNA. 6.When a patient has severe hepatic disease, which is contraindication for MTX. 7.When a patient has severe renal disease, which is contraindication for MTX 8.When a patient has concurrent malignancy, lymphoma, leukemia or lymphproliferative disorder except for skin cancer (basal cell carcinoma or epithelial cell carcinoma) and cervical cancer of uterus which were completely resected and has not recurred for more than 5 years, 9.When a patient has uncontrollable comorbidities (i.e., severe diabetes, unstable ischemic heart disease, stroke within the last 1 year). 10.A patient with latent tuberculosis unless he/she receives proper chemoprophylaxis according to the Japan College of Rheumatology guideline. 11.When a patient received investigational drug within the last month or within the five times of half-life, whichever is longer. 12.When a patient's body weight less than 40kg. 13.When a patient is under breastfeeding or pregnant, or has plan to be pregnant in 24 weeks. 14.When a doctor judges a patient cannot to visit outpatient clinic regularly for 24 weeks. 15.When a doctor judges a patient not appropriate to participate in the study.
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