The Effect of Metformin on the Clinical Outcome of Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- disease activity scale in 28 joints ( DAS-28)
研究概览
简要总结
Metformin has been used clinically for over 50 years, as a glucose lowering agent.
Direct and indirect anti-inflammatory effects of metformin have been reported in animal and clinical studies, and this effect is independent of its hypoglycemic effect.
Animal studies showed that metformin decreased serum C-reactive protein (CRP) level in atherogenic rabbits and decreased proinflammatory cytokines (interleukin (IL)-1β, IL-6 and tumor necrosis factor (TNF-α) in obese mice .
Moreover, metformin also suppressed osteoclastogenesis ; this may partially result from decreased expression of inflammatory cytokines that promote osteoclastogenesis in the arthritic joint.
The objective of this study is to evaluate the efficacy and safety of addition of metformin to standard disease modifying anti-rheumatic drugs (DMARDs) in patients with rheumatoid arthritis.
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 (Participant)
盲法说明
single blinded
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
- •Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR / EULAR 2010 criteria .
- •Patients with moderate to high disease activity (DAS - 28 . score greater than 3.2)
- •Patients received the standard therapy (i.e. one or more conventional DMARDs) for at least three months.
排除标准
- •Known hypersensitivity to metformin.
- •Patients who have a prior diagnosis with diabetes mellitus.
- •Patients receive metformin for any other indications.
- •Patients with congestive heart failure.
- •Patients with a history of myocardial infarction.
- •Patients with severe anemia.
- •Patients with active infections or other inflammatory diseases.
- •Patients receiving biological therapy.
- •Pregnancy or lactation.
- •Patients with impaired liver functions.
- •Patients with impaired kidney functions (serum creatinine concentrations ≥1.5 and ≥1.4 mg/dL in males and females respectively).
- •Patients with malignancies.
研究组 & 干预措施
Metformin Group
850 mg metformin twice daily for six months in addition to standard therapy
干预措施: Metformin (Drug)
Metformin Group
850 mg metformin twice daily for six months in addition to standard therapy
干预措施: Conventional DMARDs (Drug)
Control Group
placebo in addition to standard therapy for rheumatoid arthritis
干预措施: Conventional DMARDs (Drug)
Control Group
placebo in addition to standard therapy for rheumatoid arthritis
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
disease activity scale in 28 joints ( DAS-28)
时间窗: 6 months
scale assessing severity of rheumatoid arthritis based on number of tender , swollen joints , 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). DAS28 values range from 2 to 10 while higher values mean a higher disease activity. A DAS-28 value \< 2.6 corresponds to remission,value between 2.6 and 3.2 corresponds to a low disease activity, value between 3.2 and 5.1 corresponds to a moderate disease activity, and DAS28 value \>5.1 corresponds to a high disease activity.
次要结局
- C reactive protein levels(6 months)
- The HAQ (Health Assessment Score)(6 months)
- serum adiponectin level(6-months)
- adverse effect incidence(6 months)
研究者
Mahmoud Mustafa Mahmoud Gharib
Principal investigator
Ain Shams University