CTRI/2017/07/009079已完成3 期
A Comparative, Two Arm, Randomized, Double Blind, Parallel Group, Multicentric, Non-Inferior Clinical Study to Evaluate Efficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapy over Methotrexate Tablets 15 mg Vs. Methotrexate Tablets 25 mg for the treatment of Patients with Active Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 244
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.Subjects who had been diagnosed with active RA, according to the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) Classification Criteria for Rheumatoid Arthritis (ACR) criteria, and Disease Activity Score 28 (DAS28) greater than or equal to 3.2.
- •2.Tender joint count/swollen joint count >=6.
- •3.Patients who have failed at least one cycle of DMRD therapy, defined as subject who has failed to achieve remission after Methotrexate 15mg/week regime for 3 months.
排除标准
- •1.Subjects who have participated in other clinical studies within 3 months.
- •2.Any condition which are likely to hinder the compliance with the protocol.
- •3.Subjects suffering under treatment of any chronic infection.
- •4.Subject with history of intra-articular infection within last four weeks.
- •5.Subjects with dosage of steroids more than 7.5mg/day.
- •6.Patients not on a stable dose of steroids for last 1 month.
- •7.Patients with significant systemic manifestations of rheumatoid arthritis.
- •8.Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
研究者
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