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 (POLYbio)

January 19, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Saint-Étienne, France, 42055
        • Recruiting
        • CHU Saint Etienne
        • Sub-Investigator:
          • Thierry THOMAS, MD PhD
        • Principal Investigator:
          • Hubert MAROTTE, MD PhD
        • Sub-Investigator:
          • Astrid COASSY, MD
        • Sub-Investigator:
          • Adamah AMOUZOUGAN, MD
        • Sub-Investigator:
          • Béatrice PALLOT-PRADES, MD
        • Sub-Investigator:
          • Karima BOUSSOUALIM, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with active rheumatoid arthritis
30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
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.
Other Names:
  • Compliance Rheumatology Questionnaire
Experimental: Patients with rheumatoid arthritis into remission
30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
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.
Other Names:
  • Compliance Rheumatology Questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MTX-PG concentration
Time Frame: Hour 1
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
metabolites dosing of MTX-PG (nmol/l)
Time Frame: Hour 1
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
Hour 1
Analysis of CQR score response
Time Frame: Hour 1
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Hubert MAROTTE, MD PhD, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 8, 2020

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

July 9, 2020

First Submitted That Met QC Criteria

July 13, 2020

First Posted (Actual)

July 14, 2020

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 19, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19CH114
  • 2019-003700-12 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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