drugset / Trial / NCT03863405

Metformin Use in Rheumatoid Arthritis

NCT03863405

RandomizedParallel-groupSingle-blindTreatment

Summary

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.

Timeline

Start
2019-01-09
Primary completion
2020-01-09
Completion
2020-01-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Metformin Small molecule 850 mg
Background Hydroxychloroquine Small molecule
Background Leflunomide Small molecule
Background Methotrexate Small molecule
Background Sulfasalazine Small molecule

Indications