Systemic Lupus ErythematosusISLENCT04276701
Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
A study testing blood sample, Ultrasonography assessment and questionnaires in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 6 sites in 2 countries.
Trial summary
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD is nowadays one of the most common causes of death (27%) in lupus patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- blood sample, Ultrasonography assessment and questionnaires
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 10 Mar 2021to Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient aged over 18 years old.
- SLE diagnosis according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).
Who cannot join
- Pregnancy or breast-feeding for woman.
- Person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
France5 sites
CHU de Bordeaux - service de médecine interne
Bordeaux
CHU de Brest - service de rhumatologie
Brest
CHRU de Lille - service de Médecine Interne
Lille
AP-HP - Hôpital Cochin - service de Médecine Interne
Paris
CHU de Strasbourg - service d'Immunologie Clinique
Strasbourg
About this study
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD is nowadays one of the most common causes of death (27%) in lupus patients. While traditional CV risk factors cannot explain such increased CV morbidity associated with SLE, common disease factors shared between SLE, atherosclerosis and treatment exposure may be of outmost importance in this process. Our group made 3 findings of particular interest that could link SLE pathogenesis and atherosclerosis-associated immune dysregulation: 1/ the investigators identified specific immunometabolites (circulating nucleotide-derived metabolites adenine and N4-acetylcytidine), which are increased in the circulation of SLE patients. These immunometabolites trigger a constitutive inflammasome activation resulting in aberrant IL1-β production. Given that IL1-β inhibition was reported to significantly reduce CV events without altering lipid levels, the investigators propose that these immunometabolites may represent novel candidate biomarkers of CV risk stratification in SLE. 2/ the investigators identified OX40L as an important costimulatory molecule implicated in follicular helper T cell (Tfh) activation in SLE. Interestingly, OX40L polymorphism has been associated to both SLE and atherosclerosis, and Tfh have been recently shown to accelerate atherosclerosis progression. 3/ Immune complexes-activated platelets sustain aberrant immune response in SLE and block immunosuppressive functions of regulatory T cells (Tregs) in a P-selectin/PSGL1 dependent manner. Selectins and Tregs cell dysfunction are well accepted players in atherosclerosis pathogenesis.
Thus there are multiple pathways that are shared between SLE and atherosclerosis and that may results in an increased risk of CV-associated morbidity in SLE patients. Exploring these interconnected pathways in SLE patients together with traditional and other well-established disease-related factors, might lead to a better stratification of CV risk in SLE.
The aim of this study is to investigate the accuracy, predictive value and utility of immunological disease-related biomarkers in stratifying CV risk in patients with SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- blood sample, Ultrasonography assessment, questionnaires
- Keywords
- Immune mediators, Immune metabolites, cardio vascular diseases, Systemic Lupus Erythematosus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma
Ultrasonography assessmentOther
assessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT)
questionnairesBehavioural
Food and exercise questionnaires validated by the American heart Association
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Not described Receives: Biological: blood sample; Other: Ultrasonography assessment; Behavioral: questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who show atherosclerotic plaque progression defined by the absence of carotid plaque in patients at baseline and its subsequent development at follow-up evaluated by semi-automated 3D vascular ultrasound
Measured: At baseline (Day 0) and 18 months from baseline
Secondary outcomes (26)
Proportion of patients who show carotid Intima Media Thickness (cIMT) progression measured in the common carotid artery, at the bulb and the origin of the internal carotid artery
defined as an increase of 0.1mm or more evaluated by vascular ultrasound.
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients with atherosclerotic plaques
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients with hypertension
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients with Body Mass Index around 30 or more
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients who are smokers or past-smokers
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of ischemic heart disease
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of cerebral vascular accident
Measured: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of peripheral artery disease
Measured: At baseline (Day 0) and 18 months from baseline
Change in waist size in centimeters
Measured: At baseline (Day 0) and 18 months from baseline
Change in blood glucose levels in milligram per deciliter
Measured: At baseline (Day 0) and 18 months from baseline
Change in total cholesterol levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in HDL cholesterol levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in LDL cholesterol levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in triglycerides levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in Very Low Density Lipoprotein (VLDL) levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in C-Reactive protein levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in insulin levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in lupus disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
score (Min value: 0 - Max value: 105), with higher values mean higher disease activity.
Measured: At baseline (Day 0) and 18 months from baseline
Change in lupus disease activity according to Systemic Lupus International Collaborating Clinics /American College of Rheumatology (SLICC/ACR) damage index
(Min value: 0 - Max value: 47), with higher values mean more important damages.
Measured: At baseline (Day 0) and 18 months from baseline
Change in glucocorticoids intake
Measured: At baseline (Day 0) and 18 months from baseline
Change in platelets-derived biomarkers (P-selectin, sCD154) in micrograms per milliliter, evaluated by Western Blot analysis.
Measured: At baseline (Day 0) and 18 months from baseline
Change in neutrophils-derived biomarkers Proteins S100A8, A9, A8/9, and A12, IL-6 in micrograms per milliliter, evaluated by Western Blot analysis.
Measured: At baseline (Day 0) and 18 months from baseline
Change in interleukin-6 levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in interleukin-12 levels
Measured: At baseline (Day 0) and 18 months from baseline
Change in T-Follicular Helpers lymphocytes
Measured: At baseline (Day 0) and 18 months from baseline
Change in myeloperoxidase-conjugated DNA levels in fluorescence intensity evaluated by fluorometric assay.
Measured: At baseline (Day 0) and 18 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2020
- Study start10 Mar 2021
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Research in Rheumatology (FOREUM)
- Responsible party
- Sponsor
- Investigators
- Pierre DUFFAU, Prof, Principal investigator, University Hospital, BordeauxPatrick BLANCO, Prof, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04276701
- Sponsor's protocol ID
- CHUBX 2019/38
- Acronym
- ISLE
- Status last verified
- Jan 2026
- First submitted
- 12 Feb 2020
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Mediators and Metabolites to Stratify Systemic Lupus Erythematosus Patients at High Risk of Cardio Vascular Diseases
- ClinicalTrials.gov ID
- NCT04276701
- Acronym / sponsor ID
- ISLE / CHUBX 2019/38
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Immune mediators, Immune metabolites, cardio vascular diseases, Systemic Lupus Erythematosus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Foundation for Research in Rheumatology (FOREUM)
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 19 Feb 2020 (actual)
- 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.
Accelerated atherosclerosis is an established complication of systemic autoimmune diseases, particularly SLE. Young female patients with SLE are more likely to develop myocardial infarction than matched healthy controls, and CVD is nowadays one of the most common causes of death (27%) in lupus patients. While traditional CV risk factors cannot explain such increased CV morbidity associated with SLE, common disease factors shared between SLE, atherosclerosis and treatment exposure may be of outmost importance in this process. Our group made 3 findings of particular interest that could link SLE pathogenesis and atherosclerosis-associated immune dysregulation: 1/ the investigators identified specific immunometabolites (circulating nucleotide-derived metabolites adenine and N4-acetylcytidine), which are increased in the circulation of SLE patients. These immunometabolites trigger a constitutive inflammasome activation resulting in aberrant IL1-β production. Given that IL1-β inhibition was reported to significantly reduce CV events without altering lipid levels, the investigators propose that these immunometabolites may represent novel candidate biomarkers of CV risk stratification in SLE. 2/ the investigators identified OX40L as an important costimulatory molecule implicated in follicular helper T cell (Tfh) activation in SLE. Interestingly, OX40L polymorphism has been associated to both SLE and atherosclerosis, and Tfh have been recently shown to accelerate atherosclerosis progression. 3/ Immune complexes-activated platelets sustain aberrant immune response in SLE and block immunosuppressive functions of regulatory T cells (Tregs) in a P-selectin/PSGL1 dependent manner. Selectins and Tregs cell dysfunction are well accepted players in atherosclerosis pathogenesis.
Thus there are multiple pathways that are shared between SLE and atherosclerosis and that may results in an increased risk of CV-associated morbidity in SLE patients. Exploring these interconnected pathways in SLE patients together with traditional and other well-established disease-related factors, might lead to a better stratification of CV risk in SLE.
The aim of this study is to investigate the accuracy, predictive value and utility of immunological disease-related biomarkers in stratifying CV risk in patients with SLE.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Biological: blood sample, Other: Ultrasonography assessment, Behavioral: questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient aged over 18 years old.
- SLE diagnosis according to the 2019 European League Against Rheumatism (EULAR) / American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus
- Having signed an informed consent (at the latest on the day of inclusion and before any examination required by research).
Key exclusion criteria (2 listed)
- Pregnancy or breast-feeding for woman.
- Person concerned by articles L 1121-5 to L 1121-8 (persons deprived of their liberty by a judicial or administrative decision, minors, persons of legal age who are the object of a legal protection measure or unable to express their consent
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 |
|---|---|---|
| blood sample35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma | Biological | Systemic lupus erythematosus (SLE) |
| Ultrasonography assessmentassessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT) | Other | Systemic lupus erythematosus (SLE) |
| questionnairesFood and exercise questionnaires validated by the American heart Association | Behavioural | Systemic lupus erythematosus (SLE) |
Primary outcome
Proportion of patients who show atherosclerotic plaque progression defined by the absence of carotid plaque in patients at baseline and its subsequent development at follow-up evaluated by semi-automated 3D vascular ultrasound
Time frame: At baseline (Day 0) and 18 months from baseline
26 secondary outcomes
Proportion of patients who show carotid Intima Media Thickness (cIMT) progression measured in the common carotid artery, at the bulb and the origin of the internal carotid artery
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients with atherosclerotic plaques
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients with hypertension
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients with Body Mass Index around 30 or more
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients who are smokers or past-smokers
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of ischemic heart disease
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of cerebral vascular accident
Time frame: At baseline (Day 0) and 18 months from baseline
Proportion of patients who present a history of peripheral artery disease
Time frame: At baseline (Day 0) and 18 months from baseline
Change in waist size in centimeters
Time frame: At baseline (Day 0) and 18 months from baseline
Change in blood glucose levels in milligram per deciliter
Time frame: At baseline (Day 0) and 18 months from baseline
Change in total cholesterol levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in HDL cholesterol levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in LDL cholesterol levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in triglycerides levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in Very Low Density Lipoprotein (VLDL) levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in C-Reactive protein levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in insulin levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in lupus disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: At baseline (Day 0) and 18 months from baseline
Change in lupus disease activity according to Systemic Lupus International Collaborating Clinics /American College of Rheumatology (SLICC/ACR) damage index
Time frame: At baseline (Day 0) and 18 months from baseline
Change in glucocorticoids intake
Time frame: At baseline (Day 0) and 18 months from baseline
Change in platelets-derived biomarkers (P-selectin, sCD154) in micrograms per milliliter, evaluated by Western Blot analysis.
Time frame: At baseline (Day 0) and 18 months from baseline
Change in neutrophils-derived biomarkers Proteins S100A8, A9, A8/9, and A12, IL-6 in micrograms per milliliter, evaluated by Western Blot analysis.
Time frame: At baseline (Day 0) and 18 months from baseline
Change in interleukin-6 levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in interleukin-12 levels
Time frame: At baseline (Day 0) and 18 months from baseline
Change in T-Follicular Helpers lymphocytes
Time frame: At baseline (Day 0) and 18 months from baseline
Change in myeloperoxidase-conjugated DNA levels in fluorescence intensity evaluated by fluorometric assay.
Time frame: At baseline (Day 0) and 18 months from baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Pierre DUFFAU, Prof principal investigator
University Hospital, Bordeaux
Patrick BLANCO, Prof study director
University Hospital, Bordeaux
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample, Ultrasonography assessment and questionnaires in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 6 sites in 2 countries.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France, Germany. 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?
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?
Proportion of patients who show atherosclerotic plaque progression defined by the absence of carotid plaque in patients at baseline and its subsequent development at follow-up evaluated by semi-automated 3D vascular ultrasound (time frame: At baseline (Day 0) and 18 months from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2026.