Study on the Use of Subcuteous Use of Methotrexate in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- American College of Rheumatology 20
研究概览
简要总结
Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.
详细描述
Objective
To see the efficacy and safety of subcutaneous (SC) methotrexate (MTX) in patients suffering from active rheumatoid arthritis (RA). Methods: This was an open labeled randomized clinical trial. Total 90 patients were enrolled from out-patient and in-patients department of medicine (Rheumatology wing) Bangabandhu Sheikh Mujib Medical University. This study was done in two phases. In phase 1, after enrollment 10 mg MTX was given to all patients. After 4 weeks, the dose of MTX was increased by 5 mg. All patients were followed up at 8 weeks from enrollment for outcome measures and tolerability. In phase 2, patients who are intolerant to oral MTX will received 20 mg MTX subcutaneously (n=40). After 8 weeks the dose of MTX was increased by 5 mg. So, 25 mg MTX was given and after another 8 weeks final follow up was given both for clinical and laboratory outcome measures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must fulfill the ACR 1987 revised criteria
- •The disease should be active
- •Age 18-70 years
排除标准
- •Presence of other rheumatologic disorder
- •Pregnancy, lactating mother and women with child bearing potential failing to confirm adequate contraception
研究组 & 干预措施
Group A
Oral Methotrexate 25 mg will be given weekly
干预措施: Tab. Methotrexate 25mg/week (Drug)
Group B
Subcutaneous methotrexate will be given 25mg/week
干预措施: Inj. Methotrexate 25mg/week (Drug)
结局指标
主要结局
American College of Rheumatology 20
时间窗: "From enrollment to the end of treatment at 16 weeks"
20% reduction in disease activity
次要结局
未报告次要终点
研究者
Dr Md. Masudul Hassan
Associated Professor, Bangladesh Medical University
Bangladesh Medical University