Clinical trial • Phase IV • Musculoskeletal

METHOTREXATE for Erosive osteoarthritis

Phase IV trial of METHOTREXATE for Erosive osteoarthritis.

Overview

Trial Therapeutic Area
Musculoskeletal
Trial Disease
Erosive osteoarthritis
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
01-07-2025
First CTIS Authorization Date
17-10-2025

Trial design

Randomised, methotrexate (metoject 15 mg/0.30 ml) 15 mg weekly subcutaneous vs placebo (sodium chloride solution 0.9%)-controlled Phase IV trial in France.

Randomised
Yes
Comparator
Methotrexate (METOJECT 15 mg/0.30 ml) 15 mg weekly subcutaneous vs placebo (Sodium chloride solution 0.9%)
Target Sample Size
170
Trial Duration For Participant
365

Eligibility

Recruits 170 No vulnerable populations selected (isVulnerablePopulationSelected: false); trial enrols adults (age between 40 and 85). Subject information sheet and informed consent forms for adults are provided..

Pregnancy Exclusion
Pregnant or breast-feeding women (a urine pregnancy test will be carried out in women of childbearing age
Vulnerable Population
No vulnerable populations selected (isVulnerablePopulationSelected: false); trial enrols adults (age between 40 and 85). Subject information sheet and informed consent forms for adults are provided.

Inclusion criteria

  • {"criterion_text":"- Age between 40 and 85"}
  • {"criterion_text":"- Digital osteoarthritis (IPD and IPP) according to ACR criteria (with a hand X-ray less than 3 months old, showing at least 3 joints with digital osteoarthritis KL>=2) and symptomatic for more than three months"}
  • {"criterion_text":"- At least one radiographically confirmed erosive hand joint with a pain VAS (patient) greater than 40 according to OARSI criteria"}
  • {"criterion_text":"- Presence of at least one active synovitis on B-mode ultrasonography"}

Exclusion criteria

  • {"criterion_text":"- Injection of hyaluronic acid within the last 6 months"}
  • {"criterion_text":"- Pregnant or breast-feeding women (a urine pregnancy test will be carried out in women of childbearing age"}
  • {"criterion_text":"- Injection of cortisone derivatives within the previous 3 months"}
  • {"criterion_text":"- Presence of psoriasis"}
  • {"criterion_text":"- Inflammatory rheumatism"}
  • {"criterion_text":"- Contraindications to the use of methotrexate"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Structural damage is assessed using the Verbruggen-Veys score. The evolution of structural damage between M0 and M12, or worsening, of digital osteoarthritis of a joint will be defined by the change in stage of the Verbruggen-Veys score by at least one level","definition_or_measurement_approach":"Structural damage assessed using the Verbruggen-Veys score; evolution between baseline (M0) and month 12 (M12) defined as a change in stage of the Verbruggen-Veys score by at least one level."}

Recruitment

Planned Sample Size
170
Recruitment Window Months
35
Consent Approach
Informed consent obtained from adult participants. Subject information sheet and informed consent form for adults are provided (documents: L1_SIS and ICF adults). No minors or assent procedures indicated.

Geography

Total Number Of Sites
9
Total Number Of Participants
170

France

Earliest CTIS Part Ii Submission Date
02-09-2025
Latest Decision Or Authorization Date
28-04-2026
Processing Time Days
238
Number Of Sites
9
Number Of Participants
170

Sites

Site Name
Centre Hospitalier Universitaire De Nice
Department Name
RHUMATOLOGY
Principal Investigator Name
YACINE ALLAM
Principal Investigator Email
allam.y@chu-nice.fr
Contact Person Name
YACINE ALLAM
Contact Person Email
allam.y@chu-nice.fr
Site Name
Centre Hospitalier De Cannes Simone Veil
Department Name
RHUMATOLOGY
Principal Investigator Name
JOHANA AZULAY
Principal Investigator Email
j.azulay@ch-cannes.fr
Contact Person Name
JOHANA AZULAY
Contact Person Email
j.azulay@ch-cannes.fr
Site Name
Hopital Saint Joseph
Department Name
RHUMATOLOGY
Principal Investigator Name
DENIS ARNIAUD
Principal Investigator Email
darniaud@hopital-saint-joseph.fr
Contact Person Name
DENIS ARNIAUD
Site Name
Assistance Publique Hopitaux De Paris
Department Name
RHUMATOLOGY
Principal Investigator Name
AUGUSTIN LATOURTE
Principal Investigator Email
augustin.latourte@aphp.fr
Contact Person Name
AUGUSTIN LATOURTE
Contact Person Email
augustin.latourte@aphp.fr
Site Name
HOPITLA HENRI MONDOR
Department Name
RHUMATOLOGY
Principal Investigator Name
FLORENT EYMARD
Principal Investigator Email
FLORENT.EYMARD@APHP.FR
Contact Person Name
FLORENT EYMARD
Contact Person Email
FLORENT.EYMARD@APHP.FR
Site Name
CENTRE HOSPITALIER UNIVERSITAIRE GABRIEL MONTPIED
Department Name
RHUMATOLOGY
Principal Investigator Name
SYLVAIN MATHIEU
Principal Investigator Email
SMATHIEU@CHU-CLERMONTFERRAND.FR
Contact Person Name
SYLVAIN MATHIEU
Site Name
Assistance Publique Hopitaux De Paris
Department Name
RHUMATOLOGY
Principal Investigator Name
JEREMIE SELLAM
Principal Investigator Email
jeremie.sellam@aphp.fr
Contact Person Name
JEREMIE SELLAM
Contact Person Email
jeremie.sellam@aphp.fr
Site Name
CENTRE HOSPITALIER DEPARTEMENTAL VENDEE
Department Name
RHUMATOLOGY
Principal Investigator Name
GREGOIRE CORMIER
Principal Investigator Email
gregoire.cormier@ght85.fr
Contact Person Name
GREGOIRE CORMIER
Contact Person Email
gregoire.cormier@ght85.fr
Site Name
Centre Hospitalier D'Antibes Juan Les Pins
Department Name
RHUMATOLOGY
Principal Investigator Name
LAUREN NATELLA
Principal Investigator Email
lauren.natella@ch-antibes.fr
Contact Person Name
LAUREN NATELLA
Contact Person Email
lauren.natella@ch-antibes.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire De Nice
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
METOJECT 15 mg / 0,30 ml, solution injectable en stylo prérempli
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRADERMAL USE
Route
INTRADERMAL USE
Authorisation Status
Authorised (marketingAuthNumber: 34009 300 203 2 6, country: FR)
Starting Dose
15 mg
Dose Levels
15 mg
Frequency
15 mg/week
Maximum Dose
780
Investigational Product Name
SODIUM CHLORIDE SOLUTION 0.9%
Active Substance
SODIUM CHLORIDE SOLUTION 0.9%
Modality
Small molecule
Routes Of Administration
INTRADERMAL INJECTION
Route
INTRADERMAL INJECTION
Authorisation Status
marketingAuthNumber: -
Maximum Dose
16
Investigational Product Name
SPECIAFOLDINE 5 mg, comprimé
Active Substance
FOLIC ACID
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (marketingAuthNumber: 34009 304 089 1 9, country: FR)
Starting Dose
5 mg
Dose Levels
5 mg
Maximum Dose
260

Related trials

Other published trials that may interest you.