Trials / Completed
CompletedNCT03445871
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Blood sample | Blood samples will be collected for measuring PG-MTX blood concentration. |
| DIAGNOSTIC_TEST | CRQ | Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis. |
Timeline
- Start date
- 2018-07-02
- Primary completion
- 2020-05-28
- Completion
- 2020-05-28
- First posted
- 2018-02-26
- Last updated
- 2020-08-03
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03445871. Inclusion in this directory is not an endorsement.