Erosive Hand OsteoarthritisPhase 2/3ADEM2NCT07501507
Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments
A Phase 2/3 study testing Methotrexate Injectable Solution in people with Erosive Hand Osteoarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Erosive Hand Osteoarthritis
- What is being tested?
- Methotrexate Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2026to Feb 2028
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
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- 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,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06000
Yacine ALLAM, Dr, 492035477 ext. +33, allam.y@chu-nice.fr
About this study
Official title: Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments: A Randomised, Double-blind, Placebo-controlled Trial
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis
- Conditions
- Erosive Hand Osteoarthritis
- Being tested
- Methotrexate Injectable Solution, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methotrexate Injectable SolutionDrug
Injection of methotrexate every week during 12 month
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Methotrexate injectable | Active comparator | Not described Receives: Drug: Methotrexate Injectable Solution |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (2)
Function
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.
Measured: 12 months
Effectiveness of the treatment on pain
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start23 Sep 2026
- Primary completionFeb 2028 (estimated)
- Study completionFeb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Hand OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yacine ALLAM, Dr, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501507
- Sponsor's protocol ID
- 21-API-03
- Other IDs
- 2022-502362-24-00
- Acronym
- ADEM2
- Status last verified
- Sep 2026
- First submitted
- 1 Dec 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methotrexate Treatment in Hand Osteoarthritis Refractory to Usual Treatments: A Randomised, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07501507
- Acronym / sponsor ID
- ADEM2 / 21-API-03
- Conditions
- Erosive Hand Osteoarthritis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Feb 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate injectable | Active comparator | Drug: Methotrexate Injectable Solution |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (20 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methotrexate Injectable SolutionInjection of methotrexate every week during 12 month | Drug | Methotrexate injectable |
| PlaceboThe 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. | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Function
Time frame: 12 months
Effectiveness of the treatment on pain
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Erosive Hand Osteoarthritis
Active, not recruitingPhase 4
Methotrexate in Erosive Inflammatory Hand Osteoarthritis
Hand Osteoarthritis, Erosive Osteoarthritis
Enrolling by invitationObservational study
A 30-month Follow-up of MERINO Participants to Evaluate Long-term Effects of Methotrexate in Erosive Hand OA.
Hand Osteoarthritis, Erosive Osteoarthritis
Active, not recruiting
DIGItal Cohort Osteoarthritis Design
Arthrosis of Hand
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yacine ALLAM, Dr principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methotrexate Injectable Solution in people with Erosive Hand Osteoarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian ROUX, Pr (492035512 ext. +33, roux.c@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structural lesion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2026.