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Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients

NCT03852888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-01-21

No results posted yet for this study

Summary

Methotrexate is a key treatment for inflammatory rheumatism. Therapeutic compliance with methotrexate is difficult to measure because of a lack of objective testing; however, therapeutic compliance is essential for the proper management of a patient.

The objective is to characterize the kinetics of elimination of methotrexate and its main metabolite7-OH-methotrexate for observant patients according to treatment (dosage, administration) and patient characteristics.

Once this kinetics is characterized, it will be considered as a comparison reference to identify non-observant patients that is to say having concentrations lower than the lower bound of the confidence interval of the observed concentrations.

Conditions

Interventions

BIOLOGICAL

Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level

Each patient will have to complete a total of 8 urine samples after treatment with methotrexate. The 8 samples will be taken over one week (just before taking, then 2 hours after taking treatment and then on D3, D4, D5, D6, D7, D8 before the new dose of methotrexate).

Sponsors & Collaborators

  • CHU de Reims

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-14
Primary Completion
2020-11-23
Completion
2021-11-25

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03852888 on ClinicalTrials.gov