rheumatoid arthritis MedDRA version: 20.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859
Conditions
Interventions
Product Name: methotrexate
Product Code: 1
Pharmaceutical Form: Concentrate and solvent for cutaneous solution
Sponsors
CHU Saint-Etienne
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: RA patients in remission (DAS 283.2) with MTX treatment (= 15 mg/semaine), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (= 15 mg/semaine) treatment during the previous 3 months. Patients followed in the Rheumatology Department at the CHU de St Etienne. Social security affiliation. Signed informed consent. Age > 18 years 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Patients treated with another csDMARD. Another diagnostic than RA.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Correlation between PG-MTX concentrations and clinical response to methotrexate in rheumatoid arthritis patients;Secondary Objective: Demonstrate that PG-MTX metabolits concentration are lower in non responder patients than in responder patients. Correlation between PG-MTX and CQR score;Primary end point(s): PG-MTX concentrations;Timepoint(s) of evaluation of this end point: day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MTX-PG subtypes : PG-1,2,3,4,5-MTX CQR score ;Timepoint(s) of evaluation of this end point: day 1 | — |
Countries
France
Contacts
Public Contactproject manager
CHU Saint-Etienne
Outcome results
None listed