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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004348-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with active rheumatoid arthritis | Active Comparator | Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). |
|
| Patients with rheumatoid arthritis into remission | Active Comparator | Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Biological | Blood samples will be collected for measuring PG-MTX blood concentration. |
|
| 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 |
| 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 |
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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 :
Signed informed consent.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hubert MAROTTE, MD PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Saint Etienne | Saint-Etienne | 42100 | France |
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| CRQ | Diagnostic Test | Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis. |
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|
| Hour 1 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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