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Methotrexate and Metformin in Rheumatoid Arthritis Patients

NCT04196868 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2026-02-03

No results posted yet for this study

Summary

Methotrexate (MTX) is the anchor drug for patients with rheumatoid arthritis (RA). Despite its marked efficacy and acceptable side effect profile, about 1/3 of patients failed to reach RA remission. Metformin is the first-line therapy for type 2 diabetes. Its antioxidative and anti-inflammatory properties make it a good candidate for the treatment of inflammatory diseases such as rheumatoid arthritis.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

Metformin treatment

1500 mg once a day, per os, during six months

OTHER

Placebo

per os, during six months

DRUG

Methotrexate treatment

per os

Sponsors & Collaborators

  • Ministry for Health and Solidarity, France

    collaborator OTHER_GOV

  • University Hospital, Bordeaux

    lead OTHER

Principal Investigators

  • Christophe RICHEZ, Prof · University Hospital, Bordeaux

  • Antoine BENARD, MD, PhD · University Hospital, Bordeaux

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2024-12-19
Completion
2026-06-30

Countries

  • France

Study Locations

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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 NCT04196868 on ClinicalTrials.gov