Rheumatoid Arthritis
Conditions
Keywords
Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology
Brief summary
Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs) according to the latest European recommendations of the EULAR. Before to add a Biologic Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with active disease estimated by DAS28 (Disease activity Score 28)\> 3.2 insufficiently controlled by MTX subcutaneously and patients in remission obtained with a DAS 28 \<2.6 with methotrexate prescribed since more than 6 months at stable dose for at least 3 months, a concentration of MTX-PG will be achieved.
Detailed description
The assumption is the association between low methotrexate erythrocyte polyglutamate and low clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate. Adherence to MTX will be assessed by the Compliance Questionnaire Rheumatology (CQR). Measurement of this adherence could optimize MTX treatment prior to the use of biotherapy which is costly with a lower infectious tolerance. Correlation between its concentration and compliance assessed by CQR questionnaire will be tested.
Interventions
BIOLOGICALBlood sample
Blood samples will be collected for measuring PG-MTX blood concentration.
DIAGNOSTIC_TESTCRQ
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years and have social security affiliation. * Patients followed in the Rheumatology Department at the hospital of St Etienne. * Patients with rheumatoid arthritis and : * Either Rheumatoid arthritis patients in remission (DAS 28\<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months. * Or patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28\>3.2) with MTX treatment (≥ 15 mg/weeks), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/weeks) treatment during the previous 3 months. * Signed informed consent.
Exclusion criteria
* Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD) * Another diagnostic than rheumatoid arthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTX-PG concentration | Hour 1 | To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| different metabolites dosing of MTX-PG | Hour 1 | Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical |
| CQR score | Hour 1 | Analysis of CQR score response |
Countries
France
Outcome results
None listed