Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus (EQUAL)

March 10, 2026 updated by: Centre Hospitalier Universitaire Dijon
Systemic lupus erythematosus is a complex disease whose evaluation in everyday practice and in clinical research requires several aspects to be taken into account, in particular the impact of disease activity on quality of life. To date, the effect of systemic lupus on quality of life has only been described using generic questionnaires. Among the specific questionnaires for systemic lupus, the LupusQol, which has been validated in French, shows interesting psychometric properties. The determinants of quality of life specifically related to the disease are still unknown and could be studied using a longitudinal cohort thanks to the French version of the LupusQol.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

356

Phase

  • Not Applicable

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
      • Dijon, France, 21079
        • CHU de DIJON

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • - Patients meeting ACR 1997 classification criteria for systemic lupus erythematosus.
  • Patients able to understand written and spoken French.
  • Patients aged from 18 to 75 years
  • Patients who have received written and oral information about the research.

Exclusion Criteria:

  • - Patients aged less than 18 years
  • Patients aged more than 75 years
  • Severe mental retardation Any impairment of abilities to understand that make self-evaluation impossible

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

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Lupus erythematosus
Other: Questionnaire about quality of life and satisfaction

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
data for quality of life and satisfaction
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 months
Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20
participants will be followed for the duration of hospital stay, an expected average of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical data
Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3 months
Question about any recent hospitalization pregnancy contraception Compliance score of Girerd Fatigue score MFI-20 tobacco consumption Score of CES-D depression Score stress response WCC
participants will be followed for the duration of hospital stay, an expected average of 3 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

Investigators

  • Principal Investigator: Jean-François BESANCENOT, CHU Dijon - Department of Internal Medicine and Systemic Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 1, 2011

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

July 12, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimated)

July 22, 2013

Study Record Updates

Last Update Posted (Actual)

March 12, 2026

Last Update Submitted That Met QC Criteria

March 10, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Besancenot PHRC N 2010

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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