CTRI/2011/07/001924已完成3 期
Randomized Controlled Trial of Two different starting doses of Methotrexate in Rheumatoid arthritis - DMIRA
I0 个研究点目标入组 100 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
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
入选标准
- •1.Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
- •2.Between 18 years to 65 year of age
- •3.Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
- •4.Not on methotrexate in the last 2 months
- •5.Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
- •6.Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization
排除标准
- •1.Pregnant/Breastfeeding
- •2.Ongoing/Recent treatment with methotrexate (2 months)
- •3.Standard exclusion for MTX treatment
- •a.Chronic liver disease
- •b.Renal failure
- •c.Any leucopenia or thrombocytopenia
- •d.Breast-feeding
- •e.Desirous of pregnancy in the next 6 months
- •f.Known Hepatitis B or C positive
- •g.Known clinically relevant chronic lung disease: ILD
- •h.Tuberculosis or other active infections
- •i.Known HIV positive
研究者
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