Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate
NCT ID: NCT03445871
Last Updated: 2020-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2018-07-02
2020-05-28
Brief Summary
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Detailed Description
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Correlation between its concentration and compliance assessed by CQR questionnaire will be tested.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients with active rheumatoid arthritis
Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Blood sample
Blood samples will be collected for measuring PG-MTX blood concentration.
CRQ
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Patients with rheumatoid arthritis into remission
Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).
Blood sample
Blood samples will be collected for measuring PG-MTX blood concentration.
CRQ
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Interventions
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Blood sample
Blood samples will be collected for measuring PG-MTX blood concentration.
CRQ
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Another diagnostic than rheumatoid arthritis
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Saint Etienne
OTHER
Responsible Party
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Principal Investigators
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Hubert MAROTTE, MD PhD
Role: PRINCIPAL_INVESTIGATOR
CHU SAINT-ETIENNE
Locations
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Chu Saint Etienne
Saint-Etienne, , France
Countries
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Other Identifiers
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2017-004348-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1708155
Identifier Type: -
Identifier Source: org_study_id
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