Rheumatoid ArthritisMetUNCT03852888
Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients
A study testing Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level in people with Rheumatoid Arthritis, run by CHU de Reims at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteFrance
- Study dates
- 14 Nov 2018to 25 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patient protected by law.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate levelBiological
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate
LC-MS/MS quantification (in nM)
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2019
- Study start14 Nov 2018
- Primary completion23 Nov 2020
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03852888
- Sponsor's protocol ID
- PO18172*
- Acronym
- MetU
- Status last verified
- Dec 2021
- First submitted
- 7 Feb 2019
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38772677
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetics of Elimination of Methotrexate and Its Major Metabolite 7-OH-methotrexate for Observant Patients
- ClinicalTrials.gov ID
- NCT03852888
- Acronym / sponsor ID
- MetU / PO18172*
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 14 Nov 2018 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 25 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mtugroup | Experimental | Biological: Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate levelAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patient protected by law.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate levelEach 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). | Biological | mtugroup |
Primary outcome
Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate
Time frame: Day 8
LC-MS/MS quantification (in nM)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Results publication: PubMed 38772677Theate 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level in people with Rheumatoid Arthritis, run by CHU de Reims at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urinary concentration of methotrexate and its major metabolite 7-OH-methotrexate (time frame: Day 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03852888, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2026.