ARTHROSE DIGITALE MedDRA version: 12.0 Level: LLT Classification code 10031199 Term: Osteoarthrosis, localized, primary, involving hand
Conditions
Interventions
Trade Name: METHOTREXATE BELLON
Product Name: METHOTREXATE BELLON
Pharmaceutical Form: Cachet
Pharmaceutical form of the placebo: Cachet
Route of administration of the placebo: Oral use
Sponsors
CHU de NICE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: PATIENTS SUFFERING FROM DIGITAL ARTHROSIS CONFIRMED WITH X-RAY AND EVA=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: PSORIASIS MICROCRISTALLIN ARTHRITIS INFLAMMATORY RHEUMATISM HAND ARTIFICIAL JOINT CONTRA-INDICATION FOR USING METHOTREXATE CONTRA-INDICATION FOR USING MRI KIDNEY FAILURE LIVER FAILURE
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 DEMONSTRATE THAT TREATMENT IMPROVE QUALITY OF LIFE AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PLACEBO DEMONSTRATE THAT TREATMENT IMPROVE FUNCTIONALITY AT 3, 6 AND 12 MONTHS IN COMPARISON WITH PLACEBO 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 | — |
Countries
France
Outcome results
None listed