Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus (LES-HYDROXY)

December 23, 2025 updated by: University Hospital, Toulouse

Description of Compliance With Hydroxychloroquine Treatment in Patients With Systemic Lupus Erythematosus in a Hospital Internal Medicine Consultation

The project focuses on non-compliance in patients with systemic lupus erythematosus taking Plaquenil. More than half of patients with chronic illness are not or only poorly compliant with their treatment and lupus is one of them.

The investigators want to use an already validated existing questionnaire in English, the Morisky Medication Adherence Scale 8 (MMAS 8). These results will make it possible, after a multivariate study with reference to the gold standard which is hydroxychloroquinemia, to see which exact questions in the questionnaire can be used in general medicine practices in order to detect less or non-compliant patients as early as possible.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Toulouse, France
        • Toulouse Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patient with systemic lupus erythematosus

Description

Inclusion Criteria:

Age >18 years

  • Patient with systemic lupus erythematosus
  • Treatment with PLAQUENIL for > 6 months with dosage of hydroxychloroquinemia planned during the consultation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The Morisky Medication Adherence Scale (MMAS-8)
The Morisky Medication Adherence Scale completed by the patients
Other: The Morisky Medication Adherence Scale
The Morisky Medication Adherence Scale will be completed bu the patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-compliance with hydroxychloroquine treatment
Time Frame: Day 0
to describe the non-compliance with hydroxychloroquine treatment with the Morisky Medication Adherence Scale
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Toulouse

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 27, 2023

Primary Completion (Actual)

November 16, 2024

Study Completion (Actual)

December 16, 2024

Study Registration Dates

First Submitted

November 29, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

December 31, 2025

Last Update Submitted That Met QC Criteria

December 23, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC31/23/0473

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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