NCT03445871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

July 2, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2020

Completed
Last Updated

August 3, 2020

Status Verified

January 1, 2020

Enrollment Period

1.9 years

First QC Date

February 20, 2018

Last Update Submit

July 31, 2020

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisMethotrexateErythrocyte polyglutamateCompliance Questionnaire Rheumatology

Outcome Measures

Primary Outcomes (1)

  • MTX-PG concentration

    To compare MTX-PG concentration in patients with active rheumatoid arthritis and patients with rheumatoid arthritis in remission

    Hour 1

Secondary Outcomes (2)

  • different metabolites dosing of MTX-PG

    Hour 1

  • CQR score

    Hour 1

Study Arms (2)

Patients with active rheumatoid arthritis

ACTIVE COMPARATOR

Patients with active rheumatoid arthritis will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

Biological: Blood sampleDiagnostic Test: CRQ

Patients with rheumatoid arthritis into remission

ACTIVE COMPARATOR

Patients with rheumatoid arthritis into remission will be included. They will have a blood sample and Compliance Rheumatology Questionnaire (CRQ).

Biological: Blood sampleDiagnostic Test: CRQ

Interventions

Blood sampleBIOLOGICAL

Blood samples will be collected for measuring PG-MTX blood concentration.

Patients with active rheumatoid arthritisPatients with rheumatoid arthritis into remission
CRQDIAGNOSTIC_TEST

Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.

Also known as: Compliance Rheumatology Questionnaire
Patients with active rheumatoid arthritisPatients with rheumatoid arthritis into remission

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients treated with another conventional synthetic Disease Modifying Anti-Rheumatic Drugs (csDMARD)
  • Another diagnostic than rheumatoid arthritis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Hubert MAROTTE, MD PhD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2018

First Posted

February 26, 2018

Study Start

July 2, 2018

Primary Completion

May 28, 2020

Study Completion

May 28, 2020

Last Updated

August 3, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)