Arthrose érosive des doigts : traitement par méthotrexate versus placebo- évaluation de l’action clinique et structurale (IRM dédiée)- Etude ADEM

Conditions: ARTHROSE DIGITALE
MedDRA version: 12.0Level: LLTClassification code 10031199Term: Osteoarthrosis, localized, primary, involving hand

Registration Number: EUCTR2007-005437-11-FR

Lead Sponsor: CHU de NICE

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

PATIENTS SUFFERING FROM DIGITAL ARTHROSIS CONFIRMED WITH X-RAY AND EVA<40
STABLE ANALGESIC TREATMENT SINCE 4 WEEKS AT LEAST
NEGATIF PREGNANCY TEST

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

PSORIASIS
MICROCRISTALLIN ARTHRITIS
INFLAMMATORY RHEUMATISM
HAND ARTIFICIAL JOINT
CONTRA-INDICATION FOR USING METHOTREXATE
CONTRA-INDICATION FOR USING MRI
KIDNEY FAILURE
LIVER FAILURE

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: DEMONSTRATE THAT TREATMENT WITH METHOTREXATE IS MORE EFFICIENT ON PAIN THAT PLACEBO AFTER 3 MONTHS;Secondary Objective: DEMONSTRATE THAT AMELIORATION OF PAIN IS PERSISTING AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PLACEBO<br>DEMONSTRATE THAT TREATMENT IMPROVE QUALITY OF LIFE AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PLACEBO <br>DEMONSTRATE THAT TREATMENT IMPROVE FUNCTIONALITY AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PLACEBO <br>DEMONSTRATE THAT PATIENTS WITH TREATMENT HAVE LESS LIGAMENTARY LESION AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PATIENTS RECEIVING PLACEBO ;Primary end point(s): ASSESSMENT OF PAIN AT 3 MONTHS

Secondary Outcome Measures