Comparison of Combination of Methotrexate and Statins With Methotrexate Alone as an Anti-inflammatory Agent in the Treatment of Rheumatoid Arthritis.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28)
研究概览
简要总结
The objective of the study is to compare the efficacy of combination of Methotrexate and Statins with Methotrexate alone in the treatment of Rheumatoid Arthritis. It is hypothesized that adding statins to methotrexate for treatment of rheumatic arthritis will significantly suppress the disease activity as compared to methotrexate alone.
详细描述
After approval from Board of Studies and IRB of King Edward Medical University, all patients fulfilling inclusion and exclusion criteria from out patient department and wards of Mayo Hospital Lahore will be selected and randomized to group A or group B by lottery method (using coin flipping method) with one group receiving combination of methotrexate and simvastatin and other group receiving simvastatin only. All patients will be given adequate dose of analgesics for pain relief. Informed consent will be obtained from the patient. Demographic information like name, age and sex, will also be obtained. DAS 28 scoring will be done at the time of presentation and will be noted. Patients will be followed at 1 month, 3 month and at 6 month. At each follow up DAS 28(ESR) score will be calculated using DAS 28 calculator. All this information will be recorded on predesigned proforma (attached).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients between ages 18 years and above
- •Gender- Both male and female
- •Fulfilling 2010 ACR/EULAR criteria of Rheumatoid arthritis with active inflammatory disease defined by DAS 28 score >2.6,
- •Normal serum cholesterol level.
排除标准
- •Already diagnosed patients of Diabetes mellitus.
- •Use of steroids greater than 4 weeks of duration or intra articular steroid injection within 4 weeks of study.
- •Statin therapy in last three months.
- •Statin intolerant patient.
- •Elevated Creatinine Phosphokinase more than twice the upper limit of normal range.
- •Diagnosed case of Chronic liver disease or abnormal liver functions (transaminases > 2 times the upper limit of normal range) before the start of treatment or during follow-up.
- •High serum Creatinine level
- •Pregnancy and breast feeding.
研究组 & 干预措施
Simvastatin & Methotrexate
Methotrexate 10 mg once a week per oral for 6 months and Statins (Simvastatin) 20 mg once a day per oral
干预措施: Simvastatin 20 mg (Drug)
Simvastatin & Methotrexate
Methotrexate 10 mg once a week per oral for 6 months and Statins (Simvastatin) 20 mg once a day per oral
干预措施: Methotrexate 10 mg (Drug)
Methotrexate
Methotrexate 10 mg once a week for 6 months
干预措施: Methotrexate 10 mg (Drug)
结局指标
主要结局
Efficacy of drugs defined by improvement in Disease Activity Score 28 (DAS28)
时间窗: 6 months
In Rheumatoid arthritis, DAS28 values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS 28 below the value of 2.6 is interpreted as Remission/improvement
次要结局
- Adverse Drug Reaction(6 months)
研究者
Rabia Rathore
Associate Professor of Medicine
King Edward Medical University