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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03445871
Other study ID # 1708155
Secondary ID 2017-004348-39
Status Completed
Phase Phase 4
First received
Last updated
Start date July 2, 2018
Est. completion date May 28, 2020

Study information

Verified date January 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date May 28, 2020
Est. primary completion date May 28, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Blood sample
Blood samples will be collected for measuring PG-MTX blood concentration.
Diagnostic Test:
CRQ
Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.

Locations

Country Name City State
France Chu Saint Etienne Saint-etienne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary MTX-PG concentration To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission Hour 1
Secondary different metabolites dosing of MTX-PG Analysis of different metabolites dosing of MTX-PG by High-performance liquid chromatography technical Hour 1
Secondary CQR score Analysis of CQR score response Hour 1
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