Efficacy and Safety of Metformin (1000 mg/d) as Adjuvant to Standard of Care (SOC) in Management of Rheumatoid Arthritis: A Prospective, Randomized, Comparative Study (Version 1.0, dt. 01/07/2025)
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4
研究概览
简要总结
The primary objective of this clinical trial is to assess the efficacy of metformin in the management of Rheumatoid Arthritis (RA). The study is designed to evaluate whether metformin leads to measurable improvement in clinical symptoms and disease activity among RA patients.
The secondary objective is to evaluate the safety and tolerability of metformin in this population. This includes systematic monitoring of adverse events, treatment-emergent side effects, and patient adherence throughout the study duration.Study hypothesis:H0: There is no significant difference in the change in DAS-28 (CRP) scores between the study treatment (Metformin) and the reference (No metformin) treatment.
H1: The change (improvement) in DAS-28 (CRP) scores is greater with the study treatment (Metformin) and reference (No metformin) treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients older than 18 years (of both sexes) diagnosed with rheumatoid arthritis according to ACR or EULAR 2010 criteria.
- •Patients received the standard therapy (i.e., one or more conventional DMARDs) for at least three months
- •Diagnosed cases of Rheumatoid arthritis (Rheumatoid Arthritis factor positive).
- •Onset of symptom duration greater than or equal to 6 months at the time of screening
- •Greater than or equal to 5 score on 10-point visual analogue scale (VAS) for pain at baseline.
- •Willing to give consent for participating in the study.
排除标准
- •Patients having severe disabling arthritis in the targeted or contralateral joint.
- •Patients with radiologically abnormal knee alignment.
- •Patients with a history of Chikungunya, Dengue, or other viral infections in the past six months.
- •Participants with a history or presence of Type 1 and Type 2 diabetes.
- •Those who are on treatment with immunosuppressive drugs and biologicals
- •Participants who are taking any other oral hypoglycaemic drugs.
- •8.Participants who are prone to gastrointestinal symptoms like nausea, vomiting, diarrhoea, flatulence, and Vitamin B12 deficiency.
- •Pregnant and lactating women.
- •Any condition which, in the opinion of the investigator, will place the subject at risk or will influence the conduct of the study or interpretation of results.
- •Diagnosed cases of Gouty arthritis (Serum Uric acid greater than UNL).
- •Patient requiring any systemic analgesic for other conditions that can affect the outcome of the study drug.
- •Patient on systemic corticosteroid therapy.
- •Known case of history of allergy with NSAIDs or test drug.
- •Patients with a BMI greater than or equal to 40 kg/m2
- •Participants who have enrolled in any other trial in the past 6 months.
结局指标
主要结局
1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4
时间窗: 1.Change from baseline in Disease Activity Score-28 (DAS-28) for severity of RA at weeks 1, week 2, week 3 and week 4
次要结局
- 1. Change from baseline in PGHA domain score for pain of affected joint at weeks 1, 2, week 3 and week 4(2. Change from baseline in the Fatigue Severity Scale (FSS) for pain at weeks 1, week 2, week 3 and week 4)
研究者
DR Sachin Kale
DY Patil deemed to be University School of Medicine, Navi Mumbai