Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Response to treatment
研究概览
简要总结
Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.
详细描述
Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Patients were divided into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987
- •Age >18 years
- •Early Rheumatoid Arthritis i.e. less than 2 years duration
- •Patient giving consent to participate in study
- •Disease Modifying Anti-Rheumatic Drugs naive -
排除标准
- •Pregnant and lactating patient or planning to conceive in next year
- •Patient who had joint surgery in last 6 months
- •Co morbidities such as liver disease, kidney disease, hematological malignancies
- •Uncontrolled hypertension, diabetes mellitus
- •Coronary artery disease -
研究组 & 干预措施
Methotrexate
Single agent Methotrexate 15 to 25 mg PO per week
干预措施: Methotrexate (Drug)
Combination
Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
干预措施: Combination (Drug)
Combination Steroid
Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day Methylprednisolone 1000 mg intravenous per day for 3 days
干预措施: Combination Steroid (Drug)
结局指标
主要结局
Response to treatment
时间窗: 22 months
To compare the response (EULAR criteria) to treatment in the three treatment groups.
次要结局
- Disease activity score (DAS28)(22 months)
研究者
Atul Batra
Senio Resident
All India Institute of Medical Sciences, New Delhi