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

Centre Hospitalier Universitaire de Saint Etienne

Status and phase: Completed; Phase 4

Conditions: Rheumatoid Arthritis

Treatments: Biological: Blood sample; Diagnostic Test: CRQ

Study type: Interventional

Funder types: Other

Identifiers

NCT03445871

1708155

2017-004348-39 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Patients with active rheumatoid arthritis

Active Comparator group

Description:

Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

Treatment:

Biological: Blood sample

Diagnostic Test: CRQ

Patients with rheumatoid arthritis into remission

Active Comparator group

Description:

Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

Treatment:

Biological: Blood sample

Diagnostic Test: CRQ