A Phase 2/3 interventional study of Methotrexate Injectable Solution and Placebo in Erosive Hand Osteoarthritis, sponsored by Centre Hospitalier Universitaire de Nice. Recruiting at 1 site in France. Open to participants aged 40 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Centre Hospitalier Universitaire de Nice · Phase 2/3, Interventional, and Treatment
Among 136 studies in Osteoarthritis with a site in France — 25 open to participants now, 38 under way, 2 of them phase 3. Osteoarthritis · France.
Among the 136 studies in Osteoarthritis with a site in France, this one is the 24th largest by planned enrollment of the 86 interventional ones, is one of 9 that started in 2026, is one of 3 in phase 2/3, reaches primary completion later than 20 of the 37 other live ones, and was the 130th registered.
2,974 studies on the registry are indexed under Osteoarthritis; 438 are open to participants now.
This study's planned enrollment of 170 is above the median of 80 across 2,240 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →25 of the 136 studies in Osteoarthritis with a site in France are open now, in 8 countries. Each count lists the studies.
Of the 287 Osteoarthritis studies recruiting now, 158 (55%) set no upper age limit and 72 (25%) stop at 75 or younger; 22 take children under 18; 30 take healthy volunteers.
This study: 40 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →136 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 9 started in 2026.
Median enrollment 90 across the 86 interventional studies, 152 across the 48 observational. Of the 83 that completed or were terminated, 12 (14%) have results posted.
49 of 136 have an industry lead sponsor. The 10 most frequent:
Centre Hospitalier Universitaire de Nice is the lead sponsor of 723 studies on the registry; 176 are open to participants now.
Centre Hospitalier Universitaire de Nice has 6 studies filed under Osteoarthritis — fewer than ten, so there is no comparison to draw.
10 of the studies in Osteoarthritis with a site in France that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06902805Phase 3Assistance Publique - Hôpitaux de ParisEfficacy of Two Ultrasound-guided Intra-articular Injections of Botox® Combined With Custom-made Rigid Splinting in Painful Base-of-thumb Osteoarthritis. | 2027-05 |
| NCT06038331TBF Genie TissulaireUse of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT Osteoarthritis | 2026-11 |
| NCT07812701Assistance Publique - Hôpitaux de ParisTopical Clobetasol Propionate for Inflammatory Hand Osteoarthritis | 2026-11 |
| NCT02337244Zimmer, GmbHZimmer POLAR Persona - TKA (EMEA Study) | 2026-12 |
| NCT03372278Zimmer BiometPMCF Study on the Safety and Performance of the Zimmer® Maxera™ Acetabular System in Total Hip Arthroplasty | 2027-01 |
Among the 136 studies in Osteoarthritis with a site in France, from their registry updates:
Randomized study comparing the structural efficacy of methotrexate versus placebo in digital osteoarthritis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
- 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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Methotrexate Injectable Solution
Drug: Placebo
Injection of methotrexate every week during 12 month
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.
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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for Feb 2028, 17 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Methotrexate
Centre Hospitalier Universitaire de Nice →