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

Rheumatoid Arthritis Clinical Trial

— POLYGLU  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03445871
• Other study ID #: 1708155
• Secondary ID: 2017-004348-39
• Status: Completed
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

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