Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
研究概览
简要总结
To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects.
Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
- •Between 18 years to 65 year of age
- •Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
- •Not on methotrexate in the last 2 months
- •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
- •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
- •Pregnant/Breastfeeding
- •Ongoing/Recent treatment with methotrexate (2 months)
- •Chronic liver disease
- •Renal failure
- •Any leucopenia or thrombocytopenia
- •Breast-feeding
- •Desirous of pregnancy in the next 6 months
- •Known Hepatitis B or C positive
- •Known clinically relevant chronic lung disease: ILD
- •Tuberculosis or other active infections
- •Known HIV positive
研究组 & 干预措施
Methotrexate 7.5 mg per week
干预措施: Methotrexate (Drug)
Methotrexate 15 mg per week
干预措施: Methotrexate (Drug)
结局指标
主要结局
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
时间窗: 3 months
Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline
时间窗: 12 weeks
DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity
次要结局
- Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)(3 months)
- Proportion of Patients Who Withdrew Because of Any Cause(3 months)
- Proportion Who Withdrew Due to Intolerance(3 months)
研究者
Varun Dhir
Assistant Professor, Internal Medicine
Post Graduate Institute of Medical Education and Research, Chandigarh