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NCT04196868: METorMET²
Randomized Placebo-controlled Trial Comparing Methotrexate vs. Methotrexate/Metformin Association in Rheumatoid Arthritis Patients
Phase 2 trial testing Metformin treatment in Arthritis, Rheumatoid in 128 participants. Participants enrolled and being followed up; not accepting new ones.
19 December 2024
Quick facts
| Lead sponsor | University Hospital, Bordeaux |
|---|---|
| Phase | Phase 2 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 128 |
| Start date | 3 December 2020 |
| Primary completion | 19 December 2024 |
| Estimated completion | 1 June 2026 |
| Sites | 12 locations across France |
Drugs / interventions tested
- Metformin treatment — full drug profile →
- Placebo
- Methotrexate treatment — full drug profile →
Conditions studied
- Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →
Sponsor
University Hospital, Bordeaux
Who can join
18 and older, any sex, with Arthritis, Rheumatoid. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change of level of RA activity according to Disease Activity score on 28 joints (DAS28-ESR)
Time frame: At baseline (Day 0) and 6 months after baseline
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04196868
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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Other recruiting trials for Arthritis, Rheumatoid
Currently open trials in the same condition.
- NCT07176390 — A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) · Phase 2 · recruiting
- NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
- NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study · Phase 4 · recruiting
- NCT06492200 — Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis · NA · recruiting
- NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants · recruiting
Other University Hospital, Bordeaux trials
Trials by the same sponsor.
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- NCT07527442 — Efficacy and Safety of Circumcision Alone on Risk of Febrile Urinary Tract Infections in Boys With Posterior Urethral Va · Phase 2 · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04196868 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Bordeaux
- Last refreshed: 30 January 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04196868.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing