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

January 19, 2026 updated by: CHU de Reims

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Type of study: prospective longitudinal descriptive observational study Population: Patients treated for rheumatoid arthritis in the Rheumatology Department of Reims University Hospital and treated with methotrexate monotherapy (weekly intake).

Assessment Criteria: Urinary concentration of methotrexate and its metabolite 7-OH-methotrexate at different days post-administration.

Investigation plan: Determination of urinary methotrexate and its 7-OH-methotrexate metabolite on 8 urine samples (just before taking, then 2 hours after treatment and then on D3, D4, D5, D6, D7, D8 before re-taking methotrexate) in the same patient treated with methotrexate weekly. It will take 10 patients per dosage level, followed by 3 to 8 days post-administration, to distinguish the urinary methotrexate concentrations of observant patients from those of non-observant patients with the power of 90%.

Statistical Analysis Plan: The main objective of this study is to characterize the elimination kinetics of methotrexate and its major metabolite 7-OH-methotrexate in patients observing the various methotrexate regimens. 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.

On the one hand, simulations based on published population pharmacokinetic models of plasma methotrexate are used to estimate the periods of elimination of methotrexate. The simulations that the investigators carried out on the basis of these models highlight that these elimination periods are between 3 and at the latest 9.5 days. These periods correspond to the time required to eliminate 99% of methotrexate.

Finally, it will take 10 patients per dosage level, by administration (oral or subcutaneous), followed by the 3rd to 8th day post-administration, to distinguish urinary methotrexate concentrations from observant patients (1 +/- 0.3 nM) of non-observant patients (0.4 +/- 0.4 nM) with the power of 90%. The dosage schedules are 10, 15, 20 mg methotrexate / week per-os or subcutaneous injection. It will recruit 60 patients. The follow-up will be limited to 8 days maximum because the administration is done once a week.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • Reims, France, 51092
        • CHU Reims

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:

  • All patients managed for rheumatoid arthritis (according to the ACR / EULAR 2010 criteria) in the Rheumatology Department of the University Hospital of Reims and treated with methotrexate monotherapy.
  • Patient affiliated to a social security scheme.

Exclusion Criteria:

  • Patient protected by law.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mtugroup
All patients managed for rheumatoid arthritis (according to the ACR / EULAR 2010 criteria) in the Rheumatology Department of the University Hospital of Reims and treated with methotrexate monotherapy.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate
Time Frame: Day 8
LC-MS/MS quantification (in nM)
Day 8

Collaborators and Investigators

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

Sponsor

CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 14, 2018

Primary Completion (Actual)

November 23, 2020

Study Completion (Actual)

November 25, 2021

Study Registration Dates

First Submitted

February 7, 2019

First Submitted That Met QC Criteria

February 22, 2019

First Posted (Actual)

February 25, 2019

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 19, 2026

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PO18172*

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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