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Metformin Use in Rheumatoid Arthritis

NCT03863405 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-05-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Metformin

metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2

DRUG

Conventional DMARDs

methotrexate, leflunomide, hydroxychloroquine or sulfasalazine

DRUG

Placebo Oral Tablet

oral tablet

Sponsors & Collaborators

  • Future University in Egypt

    collaborator OTHER

  • Ain Shams University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03863405 on ClinicalTrials.gov