Association between metabolits of methotrexate and clinical response in rheumatoid arthritis patients

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003700-12-FR

Enrollment

Registered

2020-06-04

Start date

2020-03-13

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rheumatoid arthritis MedDRA version: 21.0 Level: LLT Classification code 10042952 Term: Systemic rheumatoid arthritis System Organ Class: 100000004859

Interventions

Product Name: Methotrexate Product Code: MTX Pharmaceutical Form: Concentrate and solvent for cutaneous solution Other descriptive name: METHOTREXATE DISODIUM Concentration unit: mg milligram(s) Conce

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: RA patients with MTX treatment for at least 6months, and with a stable dose for 3 months (= 15 mg/semaine) and with first bDMARD treatment for at least 6 months RA Patient in remission (DAS 283.2) Patients followed in the Rheumatology Department at the CHU de St Etienne. Social security affiliation. Signed informed consent. Age >= 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

Exclusion criteria: Patients treated with another csDMARD. Another diagnostic than RA

Design outcomes

Primary

Measure	Time frame
Main Objective: Correlation between PG-MTX concentrations and clinical response to methotrexate + first biological drug in rheumatoid arthritis patients;Secondary Objective: Demonstrate that PG-MTX metabolits concentration are lower in non responder patients than in responder patients Find association between PG-MTX metabolits concentration and Biodrugs concentration Correlation between PG-MTX metabolits concentration and CQR score ;Primary end point(s): PG-MTX concentrations;Timepoint(s) of evaluation of this end point: Day 1	—

Measure

Time frame

Main Objective: Correlation between PG-MTX concentrations and clinical response to methotrexate + first biological drug in rheumatoid arthritis patients;Secondary Objective: Demonstrate that PG-MTX metabolits concentration are lower in non responder patients than in responder patients Find association between PG-MTX metabolits concentration and Biodrugs concentration Correlation between PG-MTX metabolits concentration and CQR score ;Primary end point(s): PG-MTX concentrations;Timepoint(s) of evaluation of this end point: Day 1

—

Secondary

Measure	Time frame
Secondary end point(s): PG-MTX metabolits concentration Biodrugs concentration CQR score;Timepoint(s) of evaluation of this end point: day 1	—

Countries

France

Contacts

Public ContactProject manager

CHU Saint-Etienne

florence.rancon@chu-st-etienne.fr+330477829458

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026