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
- 260
- 试验地点
- 16
- 主要终点
- Percentage of subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response criteria.
研究概览
简要总结
This study is A Comparative, Two Arm, Randomized, DoubleBlind, Parallel Group, Multicentric, Non-Inferior Clinical Study to EvaluateEfficacy, Safety and Tolerability of Iguratimod Tablets 25 mg as an add on Therapyover Methotrexate Tablets 15 mg Vs.Methotrexate Tablets 25 mg for the treatment of Patients with Active RheumatoidArthritis. Primary objective of this trial is to study the Percentage ofsubjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50)and 70% (ACR70) response criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
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.Tender joint count/swollen joint count ≥
- •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.
- •8.Rheumatic auto-immune disease other than rheumatoid arthritis/overlap syndromes.
结局指标
主要结局
Percentage of subjects meeting the American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response criteria.
时间窗: At the end of week 28
次要结局
- Mean Change from baseline in Health Assessment Questionnaire (HAQ).(At the end of week 28)
研究者
研究点 (16)
Loading locations...
相似试验
已完成
3 期
An Efficacy and Safety Study of Fluticasone Furoate/Vilanterol 100/25 Microgram (mcg) Inhalation Powder, Fluticasone Propionate/Salmeterol 250/50 mcg Inhalation Powder, and Fluticasone Propionate 250 mcg Inhalation Powder in Adults and Adolescents With Persistent AsthmaAsthmaNCT02301975GlaxoSmithKline1,526
进行中（未招募）
3 期
Study to evaluate the Efficacy, Safety and Tolerability of Ivermectin Cream 1% w/w Vs. Azelaic Acid Gel 15% w/w in Patients with Inflammatory Lesions of Rosacea.CTRI/2017/02/007835Ajanta Pharma Limited
已完成
3 期
A clinical Trial in patients with Bacterial conjunctivitis. Clinical trial is to study efficacy, safety and tolerability of Besifloxacin ophthalmic suspension in comparison to Moxifloxacin ophthalmic solution (reference product).CTRI/2010/091/000279Ajanta Pharma Ltd200
暂停
3 期
Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following BunionectomyPain, PostoperativeNCT05324358Neumentum, Inc.341
终止
3 期
A Comparative Study of FV-100 vs. Valacyclovir for the Prevention of Post-Herpetic NeuralgiaShinglesHerpes ZosterPostherpetic NeuralgiaNCT02412917ContraVir Pharmaceuticals, Inc.237