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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04276701
Other study ID # CHUBX 2019/38
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 10, 2021
Est. completion date March 2026

Study information

Verified date October 2023
Source University Hospital, Bordeaux
Contact Pierre DUFFAU, Prof
Phone (0)5 56 79 58 28
Email pierre.duffau@chu-bordeaux.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date March 2026
Est. primary completion date March 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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). Exclusion Criteria: - 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

Study Design


Intervention

Biological:
blood sample
35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma
Other:
Ultrasonography assessment
assessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT)
Behavioral:
questionnaires
Food and exercise questionnaires validated by the American heart Association

Locations

Country Name City State
France CHU de Bordeaux - service de médecine interne Bordeaux
France CHU de Brest - service de rhumatologie Brest
France CHRU de Lille - service de Médecine Interne Lille
France AP-HP - Hôpital Cochin - service de Médecine Interne Paris
France CHU de Strasbourg - service d'Immunologie Clinique Strasbourg
Germany Universität Freiburg Freiburg

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux Foundation for Research in Rheumatology (FOREUM)

Countries where clinical trial is conducted

France,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 At baseline (Day 0) and 18 months from baseline
Secondary 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. At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients with atherosclerotic plaques At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients with hypertension At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients with Body Mass Index around 30 or more At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients who are smokers or past-smokers At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients who present a history of ischemic heart disease At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients who present a history of cerebral vascular accident At baseline (Day 0) and 18 months from baseline
Secondary Proportion of patients who present a history of peripheral artery disease At baseline (Day 0) and 18 months from baseline
Secondary Change in waist size in centimeters At baseline (Day 0) and 18 months from baseline
Secondary Change in blood glucose levels in milligram per deciliter At baseline (Day 0) and 18 months from baseline
Secondary Change in total cholesterol levels At baseline (Day 0) and 18 months from baseline
Secondary Change in HDL cholesterol levels At baseline (Day 0) and 18 months from baseline
Secondary Change in LDL cholesterol levels At baseline (Day 0) and 18 months from baseline
Secondary Change in triglycerides levels At baseline (Day 0) and 18 months from baseline
Secondary Change in Very Low Density Lipoprotein (VLDL) levels At baseline (Day 0) and 18 months from baseline
Secondary Change in C-Reactive protein levels At baseline (Day 0) and 18 months from baseline
Secondary Change in insulin levels At baseline (Day 0) and 18 months from baseline
Secondary 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. At baseline (Day 0) and 18 months from baseline
Secondary 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. At baseline (Day 0) and 18 months from baseline
Secondary Change in glucocorticoids intake At baseline (Day 0) and 18 months from baseline
Secondary Change in platelets-derived biomarkers (P-selectin, sCD154) in micrograms per milliliter, evaluated by Western Blot analysis. At baseline (Day 0) and 18 months from baseline
Secondary Change in neutrophils-derived biomarkers Proteins S100A8, A9, A8/9, and A12, IL-6 in micrograms per milliliter, evaluated by Western Blot analysis. At baseline (Day 0) and 18 months from baseline
Secondary Change in interleukin-6 levels At baseline (Day 0) and 18 months from baseline
Secondary Change in interleukin-12 levels At baseline (Day 0) and 18 months from baseline
Secondary Change in T-Follicular Helpers lymphocytes At baseline (Day 0) and 18 months from baseline
Secondary Change in myeloperoxidase-conjugated DNA levels in fluorescence intensity evaluated by fluorometric assay. At baseline (Day 0) and 18 months from baseline
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