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

NCT03852888 | Completed

• 1 other identifier: PO18172*
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate

  LC-MS/MS quantification (in nM)

  Day 8

Study Arms (1)

mtugroup

EXPERIMENTAL

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

Interventions

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

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).

mtugroup

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• Patient protected by law.

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

Location

Related Publications (1)

• Theate N, Geoffroy M, Kanagaratnam L, Gozalo C, Charlot I, Bolko L, Hittinger-Roux A, Djerada Z, Salmon JH. Urinary methotrexate dosage in rheumatoid arthritis, in patients treated for at least 6 months: a potential marker of adherence. RMD Open. 2024 May 20;10(2):e004024. doi: 10.1136/rmdopen-2023-004024.

  PMID: 38772677 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2019
• First Posted: February 25, 2019
• Study Start: November 14, 2018
• Primary Completion: November 23, 2020
• Study Completion: November 25, 2021
• Last Updated: January 21, 2026

Record last verified: 2021-12

Locations

FR (1)