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

• Register: ClinicalTrials.gov
• Last refreshed on: 10 January 2022
• Main ID: NCT03852888
• Date of registration: 07/02/2019
• Prospective Registration: No
• Primary sponsor: CHU de Reims
• Public title: Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients MetU
• Scientific title: Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients
• Date of first enrolment: November 14, 2018
• Target sample size: 62
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03852888
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

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

Primary Outcome(s)

Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate [Time Frame: Day 8]

Secondary ID(s)

PO18172*

Source(s) of Monetary Support

Please refer to primary and secondary sponsors