Rheumatoid ArthritisPhase 4POLYbioNCT04470453
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug
A Phase 4 study testing Blood sample and CRQ in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). 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?
- Blood sample and CRQ
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 8 Oct 2020to 4 Apr 2024
- Phase
- Phase 4
- 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
- Age > 18 years and have social security affiliation.
- Patients followed in the Rheumatology Department at the hospital of St Etienne.
- Rheumatoid Arthritis patients in remission (Disease Activity Score 28<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months.
- Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28>3.2) with methotrexate (MTX) treatment (≥ 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/week) treatment during the previous 3 months.
- Signed informed consent.
Who cannot join
- Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
- Another diagnostic than rheumatoid arthritis
Trial locations and contacts
1 site in 1 country.
About this study
The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Blood sample, CRQ
- Keywords
- Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
Blood samples will be collected for measuring PG-MTX blood concentration.
CRQDiagnostic test
Also called Compliance Rheumatology Questionnaire
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
| Study group | Role | What they receive |
|---|---|---|
| Patients with active rheumatoid arthritis | Experimental | 30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). Receives: Biological: Blood sample; Diagnostic Test: CRQ |
| Patients with rheumatoid arthritis into remission | Experimental | 30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). Receives: Biological: Blood sample; Diagnostic Test: CRQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTX-PG concentration
To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission
Measured: Hour 1
Secondary outcomes (2)
metabolites dosing of MTX-PG (nmol/l)
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
Measured: Hour 1
Analysis of CQR score response
Compliance Rheumatology Questionnaire (CRQ) is a 19-item self-administered questionnaire to measure overall patient compliance for both MTX and bDMARD treatment with 0 (bad compliance) and 100 (better compliance).
Measured: Hour 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start8 Oct 2020
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Why it stopped: Inclusion rate too low to meet the evaluation criterion.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert MAROTTE, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470453
- Sponsor's protocol ID
- 19CH114
- Other IDs
- 2019-003700-12, 2019
- Acronym
- POLYbio
- Status last verified
- Jan 2024
- First submitted
- 9 Jul 2020
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Biological Drug Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate and a First Biological Drug
- ClinicalTrials.gov ID
- NCT04470453
- Acronym / sponsor ID
- POLYbio / 19CH114
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion rate too low to meet the evaluation criterion.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 14 Jul 2020 (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.
The combination of methotrexate (MTX) with a biological disease-modifying antirheumatic drugs (bDMARD) is the next step in treatment with MTX monotherapy in rheumatoid arthritis (RA). Estimation of MTX and bDMARD impregnation could be performed with the erythrocyte MTX polyglutamate (MTX-PG) and bDMARD assays before to move to a second bDMARD. In RA patients treated with MTX (prescribed for at least 6 months at a stable dose for at least 3 months) in combination to a first bDMARD (prescribed since at least 3 months), an assay of MTX-PG and bDMARD will be performed in tow subsets of RA according to the level of disease activity. The first subset is active RA defined by a DAS28 (disease activity score 28)>3.2. The second one is RA in clinical remission defined by a DAS28<2.6. The main hypothesis is the association between the low concentration of MTX-PG and the clinical response of RA patients treated with subcutaneous methotrexate injection associated to a first bDMARD. Adherence to MTX will be reviewed by the Compliance Questionnaire Rheumatology (CQR) questionnaire. This assay could be useful to improve MTX management before to move to a second bDMARD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with active rheumatoid arthritis | Experimental | Biological: Blood sample, Diagnostic Test: CRQ30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). |
| Patients with rheumatoid arthritis into remission | Experimental | Biological: Blood sample, Diagnostic Test: CRQ30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years and have social security affiliation.
- Patients followed in the Rheumatology Department at the hospital of St Etienne.
- Rheumatoid Arthritis patients in remission (Disease Activity Score 28<2.6) with methotrexate (MTX) treatment for at least 6months, and with a stable dose for 3months.
- Patients with a High Disease Activity Rheumatoid Arthritis activity (Disease Activity Score 28>3.2) with methotrexate (MTX) treatment (≥ 15 mg/week), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/week) treatment during the previous 3 months.
- Signed informed consent.
Key exclusion criteria (2 listed)
- Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
- Another diagnostic than rheumatoid arthritis
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 |
|---|---|---|
| Blood sampleBlood samples will be collected for measuring PG-MTX blood concentration. | Biological | Patients with active rheumatoid arthritis, Patients with rheumatoid arthritis into remission |
| CRQAlso: Compliance Rheumatology QuestionnaireCompliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis. | Diagnostic test | Patients with active rheumatoid arthritis, Patients with rheumatoid arthritis into remission |
Primary outcome
MTX-PG concentration
Time frame: Hour 1
To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission
2 secondary outcomes
metabolites dosing of MTX-PG (nmol/l)
Time frame: Hour 1
Analysis of CQR score response
Time frame: Hour 1
Results and safety
The study was stopped early (reason given: Inclusion rate too low to meet the evaluation criterion.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Hubert MAROTTE, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood sample and CRQ in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne 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 5 inclusion and 2 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: stopped early, as of the sponsor's last update on 20 Jan 2025. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inclusion rate too low to meet the evaluation criterion.). Results are not available in the source record.
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?
MTX-PG concentration (time frame: Hour 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.