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

Rheumatoid Arthritis Clinical Trial

— POLYbio  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04470453
• Other study ID #: 19CH114
• Secondary ID: 2019-003700-12
• Status: Recruiting
• Phase: Phase 4
• Start date: October 8, 2020
• Est. completion date: January 2026

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: Hubert MAROTTE, MD PhD
• Phone: (0)477127643
• Email: hubert.marotte[@]chu-st-etienne.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years and have social security affiliation.

• Patients followed in the Rheumatology Department at the hospital of St Etienne.

• Rheumatoid Arthritis patients in remission (Disease Activity Score 28<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months.

• Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28>3.2) with methotrexate (MTX) treatment (= 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (= 15 mg/week) 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

Locations

Country	Name	City	State
France	Chu Saint Etienne	Saint-Étienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTX-PG concentration	To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission	Hour 1
Secondary	metabolites dosing of MTX-PG (nmol/l)	Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical	Hour 1
Secondary	Analysis of CQR score response	Compliance Rheumatology Questionnaire (CRQ) is a 19-item self-administered questionnaire to measure overall patient compliance for both MTX and bDMARD treatment with 0 (bad compliance) and 100 (better compliance).	Hour 1