Methotrexate treatment in hand osteoarthritis refractory to usual treatments

2022-502362-24-00 Protocol 21-API-03 Therapeutic exploratory (Phase II) Authorised, recruitment pending

Status Authorised, recruitment pending · 1 EU/EEA countries · 9 sites · Protocol 21-API-03

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)
Status Authorised, recruitment pending
Participants planned 170
Countries 1
Sites 9

Erosive osteoarthritis

Compare the efficacy of subcutaneous Methotrexate 15mg/week vs. placebo on the evolution of the disease. joint structure at 12 months in patients with erosive digital osteoarthritis

Key facts

Sponsor
Centre Hospitalier Universitaire De Nice
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Musculoskeletal Diseases [C05]
Decision date (initial)
2025-10-17
Transition trial
No
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

Compare the efficacy of subcutaneous Methotrexate 15mg/week vs. placebo on the evolution of the disease.
joint structure at 12 months in patients with erosive digital osteoarthritis

Conditions and MedDRA coding

Erosive osteoarthritis

VersionLevelCodeTermSystem organ class
21.0 LLT 10064565 Erosive osteoarthritis 10028395

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

  1. Age between 40 and 85
  2. 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
  3. At least one radiographically confirmed erosive hand joint with a pain VAS (patient) greater than 40 according to OARSI criteria
  4. Presence of at least one active synovitis on B-mode ultrasonography

Exclusion criteria 6

  1. Injection of hyaluronic acid within the last 6 months
  2. Pregnant or breast-feeding women (a urine pregnancy test will be carried out in women of childbearing age
  3. Injection of cortisone derivatives within the previous 3 months
  4. Presence of psoriasis
  5. Inflammatory rheumatism
  6. Contraindications to the use of methotrexate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. 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

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

METOJECT 15 mg / 0,30 ml, solution injectable en stylo prérempli

PRD3287849 · Product

Active substance
Methotrexate
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRADERMAL USE
Max daily dose
2 mg milligram(s)
Max total dose
780 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
L04AX03 — -
Marketing authorisation
34009 300 203 2 6
MA holder
MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
use in a new therapeutic indication

Placebo 1

Sodium Chloride Solution 0.9%

SUB20079 · Substance

Active substance
Sodium Chloride Solution 0.9%
Pharmaceutical form
SOLUTION FOR INJECTION
Route of administration
INTRADERMAL INJECTION
Max daily dose
43 µl microlitre(s)
Max total dose
16 ml millilitre(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
- — -
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Auxiliary 1

SPECIAFOLDINE 5 mg, comprimé

PRD4286156 · Product

Active substance
Folic Acid
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
700 µg microgram(s)
Max total dose
260 mg milligram(s)
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
B03BB01 — FOLIC ACID
Marketing authorisation
34009 304 089 1 9
MA holder
MERUS LABS LUXCO II S.À R.L.
MA country
France
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Nice

29 Total trials 16 Recruiting 7 Ended
Academic / Non-commercial
Sponsor organisation
Centre Hospitalier Universitaire De Nice
Address
4 Avenue Reine Victoria
City
Nice
Postcode
06000
Country
France

Scientific contact point

Organisation
Centre Hospitalier Universitaire De Nice
Contact name
Dr ALLAM

Public contact point

Organisation
Centre Hospitalier Universitaire De Nice
Contact name
Dominique DONZEAU

Locations

1 EU/EEA country · 9 investigational sites

By country

CountryMS statusPlanned subjectsSites
France Authorised, recruitment pending 170 9
Rest of world — 0 —

Investigational sites

France

9 sites · Authorised, recruitment pending
Assistance Publique Hopitaux De Paris
RHUMATOLOGY, 184 Rue Du Faubourg Saint Antoine, 75012, Paris
Centre Hospitalier D'Antibes Juan Les Pins
RHUMATOLOGY, 107 Avenue De Nice, 06606, Antibes Cedex
Hopitla Henri Mondor
RHUMATOLOGY, 1 RUE GUSTAVE EIFFEL, 94000, CRETEIL
Assistance Publique Hopitaux De Paris
RHUMATOLOGY, 2 Rue Ambroise Pare, 75475, Paris Cedex 10
Centre Hospitalier Universitaire De Nice
RHUMATOLOGY, 30 Voie Romaine, 06000, Nice
Hopital Saint Joseph
RHUMATOLOGY, 26 Boulevard De Louvain, 13008, Marseille
Centre Hospitalier Departemental Vendee
RHUMATOLOGY, BD STEPHANE MOREAU, 85925, LA ROCHE SUR YON
Centre Hospitalier Universitaire Gabriel Montpied
RHUMATOLOGY, 58 RUE MONTALEMBERT, 63000, CLERMONT FERRAND
Centre Hospitalier De Cannes Simone Veil
RHUMATOLOGY, 15 Avenue Des Broussailles, Cs 50008, Cannes Cedex

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol - Extract (for publication) D1_Comparaison protocol_2022-5023623-24-00 1
Protocol (for publication) D1_Protocol_2022-502362-24-00 1.1
Protocol (for publication) D4_Patient facing _Notice utilisation IMP 1
Protocol (for publication) D4_PATIENT facing diary_carnet suivi 0.0
Protocol (for publication) D4_Patient facing questionnaire_AUSCAN 0.0
Protocol (for publication) D4_Patient facing questionnaire_EQ5D5L 0.0
Protocol (for publication) D4_Patient facing questionnaire_MHQ_ADEM2 0.0
Protocol (for publication) D4_Patient facing questionnaire_SF36 normal 0.0
Recruitment arrangements (for publication) K1_Recruitment arrangements 0.0
Subject information and informed consent form (for publication) L1_SIS and ICF adults 1
Subject information and informed consent form (for publication) L1_SIS and ICF adults_partenaire 0.1
Subject information and informed consent form (for publication) L2_ identification patient card 0.0
Summary of Product Characteristics (SmPC) (for publication) G2_SmPC_Metoject_Pen_15_mg 1
Synopsis of the protocol (for publication) D1_Protocol synopsis FR_2022-502362-24-00 1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2025-07-01 France Acceptable
2025-10-13
 2025-10-17
2 SUBSTANTIAL MODIFICATION SM-1 2026-01-15 France Acceptable
2026-04-23
 2026-04-28

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