AzTrials
AzTrials

Rheumatoid PolyarthritisCQR-FNCT03642795

Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology)

An observational study of Rheumatoid Polyarthritis, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Polyarthritis
What is being tested?
Questionnaire
How many people
150 participants
Where
4 sitesFrance
Study dates
23 Jun 2022to Mar 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
  • 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).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Cécile Gaujoux Viala, MD contact

04 66 68 31 20

cecile.gaujoux.viala@chu-nimes.fr

France4 sites, 4 recruiting

  • CHU Bordeaux

    Bordeaux, 33000

    Christophe Richez, MD, christophe.richez@chu-bordeaux.fr

    Christophe Richez, MD

    Not yet recruiting

  • CHRU Montpellier

    Montpellier, 34295

    Jacques Morel, MD, j-morel@chu-montpellier.fr

    Jacques Morel, MD

    Not yet recruiting

  • CHU Nimes

    Nîmes, 30029

    Anissa Megzari, 04.66.68.42.36, drc@chu-nimes.fr

    Cécile Gaujoux Viala

    Recruiting

  • CHU Toulouse

    Toulouse, 31300

    Arnaud Constantin, arnaud.constantin@univ-tlse3.fr

    Arnaud Constantin, MD

    Not yet recruiting

Other trials in France

About this study

Official title: Validation of the French Version of the CQR (Compliance Questionnaire Rheumatology): Specific Tool for Evaluation of Observance of Rheumatology Treatment

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

Being tested
Questionnaire

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QuestionnaireOther

    Patients are asked to complete several questionnaires

Study groups in NCT03642795
Study groupRoleWhat they receive
Patients with rheumatoid polyarthritisNot described
Receives: Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 40 minutes

  2. Structural validity of French translation of the Compliance Questionnaire Rheumatology questionnaire

    Principal component analysis

    Measured: Baseline

Secondary outcomes (16)

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

    CQR ≥80% (observant) vs MTX PGs level

    Measured: Baseline

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

    %

    Measured: Baseline

  3. Rate of questionnaires with at least 1 missing item

    %

    Measured: Baseline

  4. Validation of the short form of the French Compliance Questionnaire Rheumatology

    5-item questionnaire

    Measured: Baseline

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

    Sensitivity and specificity compared against MTX PGs level

    Measured: Baseline

  6. Sex of observant versus non-observant patients

    male/female

    Measured: Month 1

  7. Age of observant versus non-observant patients

    years

    Measured: Month 1

  8. education level of observant versus non-observant patients

    school graduation

    Measured: Month 1

  9. profession of observant versus non-observant patients

    name of the profession

    Measured: Month 1

  10. marital status of observant versus non-observant patients

    Married, single, divorced, widowed

    Measured: Month 1

  11. Number patients observing medication

    Blood MTX PG concentration nmol/L by LC-MS/MS

    Measured: Month 1

  12. Quality of life in observant versus non-observant patients

    Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)

    Measured: Month 1

  13. Health-related quality of life in observant versus non-observant patients

    Euroqol 5 dimension 3 level questionnaire (EQ5D-3L)

    Measured: Month 1

  14. Functional incapacity in observant versus non-observant patients

    Health Assessment Questionnaire (HAQ)

    Measured: Month 1

  15. Pain experience in observant versus non-observant patients

    Pain Catastrophizing Scale (PCS-CF)

    Measured: Month 1

  16. Cognitive representations of medication in observant versus non-observant patients

    Beliefs about Medicines Questionnaire

    Measured: Month 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study start23 Jun 2022
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03642795
Sponsor's protocol ID
PHRCI/2016/CGV-01
Acronym
CQR-F
Status last verified
Nov 2025
First submitted
14 Nov 2017
Last updated
3 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Polyarthritis, run by Centre Hospitalier Universitaire de Nīmes at 4 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cécile Gaujoux Viala, MD (04 66 68 31 20, cecile.gaujoux.viala@chu-nimes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Test-retest agreement of French translation of the Compliance Questionnaire Rheumatology questionnaire (time frame: 40 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03642795.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in