Could a common diabetes pill boost arthritis remission?
NCT ID NCT04196868
First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times
Summary
This study tests whether adding metformin, a diabetes drug, to standard methotrexate therapy helps more people with rheumatoid arthritis achieve disease control. About 128 adults with active RA who have not recently taken methotrexate will receive either methotrexate plus metformin or methotrexate plus a placebo. The goal is to see if the combination reduces joint inflammation and disease activity better than methotrexate alone.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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128 people
The number who actually took part.
- Started
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Dec 2020
- Finished
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Jun 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged over 18 years old, * Patient affected by RA according to American College of Rheumatology (ACR) 2010 criteria * DAS28-ESR \> 3.2 * Methotrexate naïve patients, or without any methotrexate intake for more than six months. * Men who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment. Partner of patient will be informed of teratogenicity of MTX and will be advised to be on effective contraceptives for all the study duration. OR * Women with a negative test of β-human chorionic gonadotropin (HCG) who accept to take active contraception during the study and during six months after the end of the Methotrexate treatment * Patients without any Metformin previous therapy. * Being affiliated to a health insurance system * Having signed an informed consent form (later than the day of inclusion and before any examination required by the research) Exclusion Criteria: * Patient who present contraindications to treatment with Methotrexate or Metformin * Patient with type 1 or type 2 diabetes * Patient with daily corticosteroid treatment at a dosage ≥ 15 mg/day within four weeks before the inclusion * History of allergy or intolerance to biguanide * Presence of anemia (hemoglobin \< 80 g/l), neutropenia (neutrophils count \< 1500 mm3), lymphopenia (lymphocytes count \< 750 mm3), thrombopenia (platelets \< 100 000/mm3) or bone marrow hypoplasia. * Renal insufficiency with clearance \< 50 ml/mn * Decompensated heart failure * Uncontrolled heart history * Severe respiratory insufficiency * Hepatic insufficiency, or bilirubin level upper than 5mg/dl (85,5 µmol/l), or aspartate transaminase (ASAT) / alanine aminotransferase (ALAT) more than twice the standard level. * Acute or chronic infection, such as tuberculosis or HIV * Critical ischemia of the lower limbs * Recent stroke * Patient with pleural effusion, or ascites * Patient with stomatitis, mouth ulcers, or active gastrointestinal ulcer. * Patient with alcohol intoxication * B12 Vitamin deficiency * Patient performing or planning to perform a long-fasting period * Pregnant or breastfeeding women * Patient concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CH de Cahors - service de rhumatologie
Cahors, France
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CH de Libourne - service de rhumatologie
Libourne, France
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CH de Pau - service de rhumatologie
Pau, France
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CH de la Côte Basque - service de rhumatologie
Bayonne, France
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CH du Mans - service de rhumatologie
Le Mans, France
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CHD de Vendée - service de rhumatologie
La Roche-sur-Yon, France
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CHR Orléans la Source - service de rhumatologie
Orléans, France
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CHU de Bordeaux - service de rhumatologie
Bordeaux, France
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CHU de Brest - service de rhumatologie
Brest, France
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CHU de Montpellier - service de rhumatologie
Montpellier, France
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CHU de Toulouse - service de rhumatolgie
Toulouse, France
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Clinique de l'Infirmerie protestante de Lyon - service de rhumatologie
Caluire-et-Cuire, France
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