Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

NCT07501507 | Not Yet Recruiting Phase 2

• 2 other identifiers: 21-API-032022-502362-24-00
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erosive Hand Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Structural lesion

  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.

  12 months

Secondary Outcomes (2)

• Function

  12 months

• Effectiveness of the treatment on pain

  12 months

Study Arms (2)

Methotrexate injectable

ACTIVE COMPARATOR

Drug: Methotrexate Injectable Solution

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Methotrexate Injectable Solution DRUG

Injection of methotrexate every week during 12 month

Methotrexate injectable

Placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

Study Officials

• Yacine ALLAM, Dr

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christian ROUX, Pr

CONTACT

492035512; roux.c@chu-nice.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2025
• First Posted: March 30, 2026
• Study Start: May 2, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

FR (1)