- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04470453
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 (POLYbio)
January 19, 2024 updated by: Centre Hospitalier Universitaire de Saint Etienne
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Florence RANCON, CRA
- Phone Number: +33 (0)477120284
- Email: florence.rancon@chu-st-etienne.fr
Study Contact Backup
- Name: Hubert MAROTTE, MD PhD
- Phone Number: +33 (0)477127643
- Email: hubert.marotte@chu-st-etienne.fr
Study Locations
-
-
-
Saint-Étienne, France, 42055
- Recruiting
- CHU Saint Etienne
-
Sub-Investigator:
- Thierry THOMAS, MD PhD
-
Principal Investigator:
- Hubert MAROTTE, MD PhD
-
Sub-Investigator:
- Astrid COASSY, MD
-
Sub-Investigator:
- Adamah AMOUZOUGAN, MD
-
Sub-Investigator:
- Béatrice PALLOT-PRADES, MD
-
Sub-Investigator:
- Karima BOUSSOUALIM, MD
-
-
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:
- 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.
Exclusion Criteria:
- Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
- Another diagnostic than rheumatoid arthritis
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: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with active rheumatoid arthritis
30 patients with active rheumatoid arthritis will be included.
They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
|
Blood samples will be collected for measuring PG-MTX blood concentration.
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Other Names:
|
Experimental: Patients with rheumatoid arthritis into remission
30 patients with rheumatoid arthritis into remission will be included.
They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
|
Blood samples will be collected for measuring PG-MTX blood concentration.
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Hour 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
metabolites dosing of MTX-PG (nmol/l)
Time Frame: Hour 1
|
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
|
Hour 1
|
Analysis of CQR score response
Time Frame: Hour 1
|
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).
|
Hour 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Hubert MAROTTE, MD PhD, Chu Saint-Etienne
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)
October 8, 2020
Primary Completion (Estimated)
January 1, 2026
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
July 9, 2020
First Submitted That Met QC Criteria
July 13, 2020
First Posted (Actual)
July 14, 2020
Study Record Updates
Last Update Posted (Actual)
January 22, 2024
Last Update Submitted That Met QC Criteria
January 19, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19CH114
- 2019-003700-12 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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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