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Clinical Trials in France / NCT07501507
Recruiting Phase 2/3

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

NCT07501507 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire de Nice
Phase
Phase 2/3
Started
2026-09-23
Last updated
2026-09-24

Condition(s) studied

Erosive Hand Osteoarthritis

Investigational drug(s) / intervention(s)

Methotrexate Injectable Solution →Placebo

Methotrexate Injectable Solution: Injection of methotrexate every week during 12 month

Placebo: The placebo consists of a 0.9% solution of sodium chloride (NaCl) in sterile distilled water for injection. This solution was chosen as the placebo. Injection every week during 12 month.

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
85 Years
Healthy volunteers
No
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,

Primary outcome measure(s)

  • Structural lesion — 12 months
    The progression of structural damage between M0 and M12, the worsening of digital osteoarthritis in a joint, will be defined by the change in stage of the Verbruggen-Veys score. The Verbruggen-Veys anatomical scoring system for hand osteoarthritis, which evaluates the radiographic progression of interphalangeal joints. This scale classifies each joint into five stages (N, S, J, E, R) reflecting increasing severity of structural damage. Progression is defined as a transition to a more advanced stage between M0 and M12. As this is a categorical ordinal scale rather than a continuous numerical score, there are no minimum or maximum numerical values. However, higher stages correspond to more severe structural damage and thus a worse outcome.

Trial sites (1)

FacilityCityRegionStatus
CHU de Nice Nice France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07501507 on ClinicalTrials.gov ↗ ← All trials in France