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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)

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
Blood sample
CRQ
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Saint EtienneRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Patients with active rheumatoid arthritis

Patients with rheumatoid arthritis into remission

Arm Description

30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

Outcomes

Primary Outcome Measures

MTX-PG concentration
To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission

Secondary Outcome Measures

metabolites dosing of MTX-PG (nmol/l)
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
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).

Full Information

First Posted
July 9, 2020
Last Updated
April 25, 2023
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT04470453
Brief 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
Acronym
POLYbio
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, Methotrexate, Erythrocyte polyglutamate, Compliance Questionnaire Rheumatology

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients with active rheumatoid arthritis
Arm Type
Experimental
Arm Description
30 patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Arm Title
Patients with rheumatoid arthritis into remission
Arm Type
Experimental
Arm Description
30 patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Intervention Type
Biological
Intervention Name(s)
Blood sample
Intervention Description
Blood samples will be collected for measuring PG-MTX blood concentration.
Intervention Type
Diagnostic Test
Intervention Name(s)
CRQ
Other Intervention Name(s)
Compliance Rheumatology Questionnaire
Intervention Description
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Primary Outcome Measure Information:
Title
MTX-PG concentration
Description
To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission
Time Frame
Hour 1
Secondary Outcome Measure Information:
Title
metabolites dosing of MTX-PG (nmol/l)
Description
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
Time Frame
Hour 1
Title
Analysis of CQR score response
Description
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).
Time Frame
Hour 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hubert MAROTTE, MD PhD
Phone
(0)477127643
Ext
+33
Email
hubert.marotte@chu-st-etienne.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Florence RANCON, CRA
Phone
(0)477120284
Ext
+33
Email
florence.rancon@chu-st-etienne.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubert MAROTTE, MD PhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint Etienne
City
Saint-Étienne
ZIP/Postal Code
42055
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hubert MAROTTE, MD PhD
First Name & Middle Initial & Last Name & Degree
Thierry THOMAS, MD PhD
First Name & Middle Initial & Last Name & Degree
Béatrice PALLOT-PRADES, MD
First Name & Middle Initial & Last Name & Degree
Karima BOUSSOUALIM, MD
First Name & Middle Initial & Last Name & Degree
Adamah AMOUZOUGAN, MD
First Name & Middle Initial & Last Name & Degree
Astrid COASSY, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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