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Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate (POLYGLU)

Primary Purpose

Rheumatoid Arthritis

Status
Completed
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.

  • Patients with rheumatoid arthritis and :

    • Either Rheumatoid arthritis patients in remission (DAS 28<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months.
    • Or patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2) with MTX treatment (≥ 15 mg/weeks), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/weeks) 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 Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients with active rheumatoid arthritis

Patients with rheumatoid arthritis into remission

Arm Description

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 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

different metabolites dosing of MTX-PG
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
CQR score
Analysis of CQR score response

Full Information

First Posted
February 20, 2018
Last Updated
July 31, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03445871
Brief Title
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate
Acronym
POLYGLU
Official Title
Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
May 28, 2020 (Actual)
Study Completion Date
May 28, 2020 (Actual)

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
Methotrexate (MTX) is the first-line treatment of rheumatoid arthritis (RA). In case of MTX failure, it is discussed to start a Biologic Disease-modifying Antirheumatic Drug (bDMARDs) according to the latest European recommendations of the EULAR. Before to add a Biologic Disease-modifying Antirheumatic Drug (bDMARDs), an objective estimation of MTX impregnation could be carried out by MTX polyglutamates (MTX-PG). In rheumatoid arthritis patients with active disease estimated by DAS28 (Disease activity Score 28)> 3.2 insufficiently controlled by MTX subcutaneously and patients in remission obtained with a DAS 28 <2.6 with methotrexate prescribed since more than 6 months at stable dose for at least 3 months, a concentration of MTX-PG will be achieved.
Detailed Description
The assumption is the association between low methotrexate erythrocyte polyglutamate and low clinical response in rheumatoid arthritis patients treated with subcutaneous injectable methotrexate. Adherence to MTX will be assessed by the Compliance Questionnaire Rheumatology (CQR). Measurement of this adherence could optimize MTX treatment prior to the use of biotherapy which is costly with a lower infectious tolerance. Correlation between its concentration and compliance assessed by CQR questionnaire will be tested.

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 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with active rheumatoid arthritis
Arm Type
Active Comparator
Arm Description
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
Active Comparator
Arm Description
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
different metabolites dosing of MTX-PG
Description
Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical
Time Frame
Hour 1
Title
CQR score
Description
Analysis of CQR score response
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. Patients with rheumatoid arthritis and : Either Rheumatoid arthritis patients in remission (DAS 28<2.6) with MTX treatment for at least 6months, and with a stable dose for 3months. Or patients with a High Disease Activity Rheumatoid Arthritis activity (DAS 28>3.2) with MTX treatment (≥ 15 mg/weeks), taking MTX treatment for at least 6months with a stable subcutaneous weekly MTX injection (≥ 15 mg/weeks) 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
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-etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate

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