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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03445871 |
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Date of registration:
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20/02/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate
POLYGLU |
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Scientific title:
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Association Between Methotrexate Erythrocyte Polyglutamate Concentration and Clinical Response in Rheumatoid Arthritis Patients Treated With Subcutaneous Injectable Methotrexate |
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Date of first enrolment:
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July 2, 2018 |
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Target sample size:
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60 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03445871 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Hubert MAROTTE, MD PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU SAINT-ETIENNE |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Biological: Blood sample
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Diagnostic Test: CRQ
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Primary Outcome(s)
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MTX-PG concentration
[Time Frame: Hour 1]
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Secondary Outcome(s)
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different metabolites dosing of MTX-PG
[Time Frame: Hour 1]
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CQR score
[Time Frame: Hour 1]
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Secondary ID(s)
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2017-004348-39
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1708155
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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