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NCT Number: NCT07501507

Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments

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

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Key information

Conditions

Erosive Hand Osteoarthritis

Age range

40 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Methotrexate Injectable Solution

Drug

Injection of methotrexate every week during 12 month

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.

Primary outcomes

  1. Structural lesion

    Time frame: 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.

Secondary outcomes

  1. Function

    Time frame: 12 months

    Hand function will be assessed using the Australian/Canadian Osteoarthritis Hand Index (AUSCAN). The AUSCAN is a validated patient-reported outcome measure that evaluates pain, stiffness, and physical function in hand osteoarthritis. The function subscale consists of 9 items, each scored on a Likert scale. The total function score ranges from 0 to 36, with higher scores indicating worse functional impairment. Changes in the AUSCAN function score between baseline (M0) and 12 months (M12) will be analyzed.

  2. Effectiveness of the treatment on pain

    Time frame: 12 months

    The effectiveness of the treatment on pain will be assessed using a Visual Analog Scale (VAS) for pain, a validated patient-reported outcome measure.

    The VAS consists of a 100 mm horizontal line, where 0 mm indicates "no pain" and 100 mm indicates "worst imaginable pain".

    The outcome will be expressed as the mean pain score (in millimeters) and the change in pain score from baseline (M0) at each time point (M3, M9, and M12).

    Higher scores indicate greater pain intensity and therefore a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Christian ROUX, Pr

CONTACT

[email protected]

492035512 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: ADEM2

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 30, 2026
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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