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

NCT04470453 | Terminated Phase 4

• 2 other identifiers: 19CH1142019-003700-12
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Methotrexate; Erythrocyte polyglutamate; Compliance Questionnaire Rheumatology

Outcome Measures

Primary Outcomes (1)

• MTX-PG concentration

  To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission

  Hour 1

Secondary Outcomes (2)

• metabolites dosing of MTX-PG (nmol/l)

  Hour 1

• Analysis of CQR score response

  Hour 1

Study Arms (2)

Patients with active rheumatoid arthritis

EXPERIMENTAL

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

Biological: Blood sample; Diagnostic Test: CRQ

Patients with rheumatoid arthritis into remission

EXPERIMENTAL

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

Biological: Blood sample; Diagnostic Test: CRQ

Interventions

Blood sample BIOLOGICAL

Blood samples will be collected for measuring PG-MTX blood concentration.

Patients with active rheumatoid arthritis; Patients with rheumatoid arthritis into remission

CRQ DIAGNOSTIC_TEST

Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.

Also known as: Compliance Rheumatology Questionnaire

Patients with active rheumatoid arthritis; Patients with rheumatoid arthritis into remission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
• Another diagnostic than rheumatoid arthritis

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Hubert MAROTTE, MD PhD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2020
• First Posted: July 14, 2020
• Study Start: October 8, 2020
• Primary Completion: April 4, 2024
• Study Completion: April 4, 2024
• Last Updated: January 20, 2025

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)