NCT03642795

Brief Summary

The purpose of this study is to develop a French language version of the Compliance-Questionnaire-Rheumatology for use in French and Francophone rheumatology services

Trial Health

77
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
34mo left

Started Jun 2022

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
recruiting

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

Study Progress58%
Jun 2022Mar 2029

First Submitted

Initial submission to the registry

November 14, 2017

Completed
9 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
3.8 years until next milestone

Study Start

First participant enrolled

June 23, 2022

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2029

Last Updated

December 3, 2025

Status Verified

November 1, 2025

Enrollment Period

6.7 years

First QC Date

November 14, 2017

Last Update Submit

November 25, 2025

Conditions

Rheumatoid Polyarthritis

Outcome Measures

Primary Outcomes (2)

  • Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire

    Intraclass correlation and Kappa coefficient of 2 evaluations taken 40 minutes apart

    40 minutes

  • Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

    Principal component analysis

    Baseline

Secondary Outcomes (16)

  • Validation of the Compliance Questionnaire Rheumatology against gold standard (erythrocyte methotrexate polyglutamates (MTX PGs) concentration)

    Baseline

  • Rate of missing responses to each question of French translation of Compliance Questionnaire Rheumatology

    Baseline

  • Rate of questionnaires with at least 1 missing item

    Baseline

  • Validation of the short form of the French Compliance Questionnaire Rheumatology

    Baseline

  • Compare French Compliance Questionnaire Rheumatology results against general questionnaire Morisky Medication Adherence Scale (MMAS-8)

    Baseline

  • +11 more secondary outcomes

Study Arms (1)

Patients with rheumatoid polyarthritis

Other: Questionnaire

Interventions

QuestionnaireOTHER

Patients are asked to complete several questionnaires

Patients with rheumatoid polyarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months being followed in the rheumatology department of Montpellier, Toulouse, Bordeaux or Nîmes hospitals.

You may qualify if:

  • The patient must have given their free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
  • The patient is at least 18 years old
  • The patient has rheumatoid polyarthritis as defined by the ACR-EULAR 2010 criteria, treated orally or subcutaneously with MTX for at least 3 months with a stable (unchanged) dosage for at least 1 month, and a stable (unchanged) route of administration for at least 1 month. And no planned change in Methotrexate intake at least until the second study visit. Other treatments at the same time are authorized

You may not qualify if:

  • The subject refuses to sign the consent
  • It is impossible to give the subject informed information
  • The patient is under safeguard of justice or state guardianship
  • The subject has a contraindication to taking methotrexate (including a patient with a desire to become pregnant).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

CHU Bordeaux

Bordeaux, 33000, France

NOT YET RECRUITING

CHRU Montpellier

Montpellier, 34295, France

NOT YET RECRUITING

CHU Nimes

Nîmes, 30029, France

RECRUITING

CHU Toulouse

Toulouse, 31300, France

NOT YET RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Cécile Gaujoux Viala, MD

CONTACT

04 66 68 31 20cecile.gaujoux.viala@chu-nimes.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2017

First Posted

August 22, 2018

Study Start

June 23, 2022

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Last Updated

December 3, 2025

Record last verified: 2025-11

Locations

FR(4)