Lupus ErythematosusEQUALNCT01904812
Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
A study testing Questionnaire about quality of life and satisfaction in people with Lupus Erythematosus, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lupus Erythematosus
- What is being tested?
- Questionnaire about quality of life and satisfaction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2011to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Lupus Erythematosus
- Being tested
- Questionnaire about quality of life and satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire about quality of life and satisfactionOther
| Study group | Role | What they receive |
|---|---|---|
| Lupus erythematosus | Other | Not described Receives: Other: Questionnaire about quality of life and satisfaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
data for quality of life and satisfaction
Quality of life and satisfaction will be evaluate by questionnaire as Questionnaire SLEQOL, QUESTIONNAIRE LUPUSQOL, QUESTIONNAIRE MFI-20
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 months
Secondary outcomes (1)
Clinical data
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
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startDec 2011
- Primary completionMay 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François BESANCENOT, Principal investigator, CHU Dijon - Department of Internal Medicine and Systemic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904812
- Sponsor's protocol ID
- Besancenot PHRC N 2010
- Acronym
- EQUAL
- Status last verified
- Mar 2026
- First submitted
- 12 Jul 2013
- Last updated
- 12 Mar 2026
- Results posted
- No
Publications
Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.
PubMed 31620787Thibault T, Bourredjem A, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Audia S, Arnaud L, Amoura Z, Devilliers H; EQUAL Study Group. The mediating effect of fatigue in impaired quality of life in systemic lupus erythematosus: mediation analysis of the French EQUAL cohort. Rheumatology (Oxford). 2023 Sep 1;62(9):3051-3058. doi: 10.1093/rheumatology/kead020.
PubMed 36655762
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Quality of Life and Activity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT01904812
- Acronym / sponsor ID
- EQUAL / Besancenot PHRC N 2010
- Conditions
- Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Dec 2011 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 22 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lupus erythematosus | Other | Other: Questionnaire about quality of life and satisfaction |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- - 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.
Key exclusion criteria (3 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire about quality of life and satisfaction | Other | Lupus erythematosus |
Primary outcome
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
1 secondary outcome
Clinical data
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Results publication: PubMed 31620787Corneloup M, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Berthier S, Arnaud L, Bourredjem A, Amoura Z, Devilliers H; EQUAL Study Group. Disease-specific quality of life following a flare in systemic lupus erythematosus: an item response theory analysis of the French EQUAL cohort. Rheumatology (Oxford). 2020 Jun 1;59(6):1398-1406. doi: 10.1093/rheumatology/kez451.
- Derived from this study: PubMed 36655762Thibault T, Bourredjem A, Maurier F, Wahl D, Muller G, Aumaitre O, Seve P, Blaison G, Pennaforte JL, Martin T, Magy-Bertrand N, Audia S, Arnaud L, Amoura Z, Devilliers H; EQUAL Study Group. The mediating effect of fatigue in impaired quality of life in systemic lupus erythematosus: mediation analysis of the French EQUAL cohort. Rheumatology (Oxford). 2023 Sep 1;62(9):3051-3058. doi: 10.1093/rheumatology/kead020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François BESANCENOT principal investigator
CHU Dijon - Department of Internal Medicine and Systemic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire about quality of life and satisfaction in people with Lupus Erythematosus, run by Centre Hospitalier Universitaire Dijon at 1 site 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 3 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: finished, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 NCT01904812, which also lists 2 linked publications.
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 12 Mar 2026.