Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Study Overview
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Brief Summary
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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
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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.

Official Title
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Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Blood sample
* Diagnostic Test: CRQ


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with active rheumatoid arthritis<br>Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). | Biological: Blood sample<br>* Blood samples will be collected for measuring PG-MTX blood concentration.<br>Diagnostic Test: CRQ<br>* Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.<br>* Other names: Compliance Rheumatology Questionnaire;|
| Active Comparator: Patients with rheumatoid arthritis into remission<br>Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). | Biological: Blood sample<br>* Blood samples will be collected for measuring PG-MTX blood concentration.<br>Diagnostic Test: CRQ<br>* Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.<br>* Other names: Compliance Rheumatology Questionnaire;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MTX-PG concentration | To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission | Hour 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| different metabolites dosing of MTX-PG | Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical | Hour 1 | 
| CQR score | Analysis of CQR score response | Hour 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology