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Could a common diabetes pill boost arthritis remission?

NCT ID NCT04196868

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

128 people

The number who actually took part.

Started

Dec 2020

Finished

Jun 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

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

  • CH de Cahors - service de rhumatologie

    Cahors, France

  • CH de Libourne - service de rhumatologie

    Libourne, France

  • CH de Pau - service de rhumatologie

    Pau, France

  • CH de la Côte Basque - service de rhumatologie

    Bayonne, France

  • CH du Mans - service de rhumatologie

    Le Mans, France

  • CHD de Vendée - service de rhumatologie

    La Roche-sur-Yon, France

  • CHR Orléans la Source - service de rhumatologie

    Orléans, France

  • CHU de Bordeaux - service de rhumatologie

    Bordeaux, France

  • CHU de Brest - service de rhumatologie

    Brest, France

  • CHU de Montpellier - service de rhumatologie

    Montpellier, France

  • CHU de Toulouse - service de rhumatolgie

    Toulouse, France

  • Clinique de l'Infirmerie protestante de Lyon - service de rhumatologie

    Caluire-et-Cuire, France

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