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NCT07501507From ClinicalTrials.govRecruiting

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments: A Randomised, Double-blind, Placebo-controlled Trial

  • Erosive Hand Osteoarthritis

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Centre Hospitalier Universitaire de Nice
Enrolment target
170
Started
23 September 2026
Main results due
February 2028
Study sites
1
Registry updated
24 September 2026

Can you take part?

  • Ages 40 years to 85 years.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

\- Digital osteoarthritis (IPD and IPP) according to ACR criteria (with an X-ray of the hands taken less than 3 months ago, showing at least 3 joints with digital osteoarthritis KL\>=2) and symptomatic for more than three months

Exclusion Criteria:

* Having a bilirubin level \> 5 mg/dl (85.5 µmol/l)
* Pregnant or breastfeeding women (a urine pregnancy test will be performed on women of childbearing age),
* Injection of hyaluronic acid within the previous 6 months,
* Injection of cortisone derivatives within the previous 3 months,
* Presence of psoriasis,
* Inflammatory rheumatism,
* Microcrystalline arthropathy,
* Joint prosthesis in one of the joints of the hand,
* Planned placement of a joint prosthesis in the hand during the study period,
* Major progressive disease (life-threatening cardiovascular disease, hematopoietic cancers including myeloma, cancers with risk of bone metastases),
* Liver failure.
* Severe renal failure (creatinine clearance less than 50 ml/min).
* Positive hepatitis B serology.
* Tuberculosis, hepatitis C, HIV positive, or other immunodeficiency syndromes.
* Uncontrolled infections.
* Use of corticosteroids.
* Use of morphine derivatives,
* Taking Bactrim,
* Taking high doses of aspirin (greater than or equal to 500mg/day),
* Contraindications to the use of methotrexate,

What this study is about

In the sponsor’s own words, from the registry.

Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis

Study sites(1)

  • CHU de Nice

    Nice, France

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07501507. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments | Trialion