Rebamipide as an Adjunct to Methotrexate in Patients With Active Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ACR20
研究概览
简要总结
Although the aetiology of RA remains to be fully elucidated, interleukin (IL)-17 are believed to play a critical role in the pathogenesis of RA. Rebamipide is an antiulcer drug that protects gastric epithelial cells,improves gastric defense mechanisms by increasing gastric mucus. Rebamipide inhibited interleukin (IL)-17, also it inhibits IL-1β-induced RASF proliferation.
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
- Double (Participant, Investigator)
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
- •patients with active rheumatoid arthritis (disease activity score-28 joints: DAS-28 > 3.2) based on the 2010 American College of Rheumatology (ACR) criteria16 were recruited.
- •rheumatoid Patients who received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
排除标准
- •History of biological DMARDS.
- •History of gastrointestinal surgery, GI ulceration,GI bleeding
- •Intolerance or allergy to rebamibide or methotrexate
- •Smoking or alcohol abuse
- •Any changes in using medication (changing the dosage or type of medicines)
- •Receive hormone replacement therapy, warfarin, and other anticoagulants
研究组 & 干预措施
placebo
patients will receive the standard therapy (methotrexate) plus placebo tablets
干预措施: Placebo (Drug)
rebamipide
100 mg rebamipide taken orally daily plus Methotrexate 15 mg weekly
干预措施: Rebamipide (Drug)
结局指标
主要结局
ACR20
时间窗: at baseline and at week 12
based on tender and swollen joint counts, patient's assessment of pain
Disease activity scale in 28 joints (DAS-28)
时间窗: at baseline and at week 12
Scale assessing severity of rheumatoid arthritis based on number of tender, swollen joints, erythrocyte sedimentation rate (ESR) levels, and patient self-assessment of his condition (global health assessment). Whereas "28" describes the number of different joints including in the measurement: proximal interphalangeal joints (10 joints), metacarpophalangeal joints (10), wrists (2), elbows (2), shoulders (2), knees (2).
次要结局
- HAQ-DI (Health Assessment Score- Disability index)(at baseline and at week 12)
- CRP(at baseline and at week 12)
研究者
engy wahsh
lecturer of clinical pharmacy
October 6 University