Systemic Lupus Erythematosus and Accelerated Aging (LUPAGE)

The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: blood sample; Biological: blood sample

Detailed Description

Systemic lupus erythematosus (SLE) is a chronic systemic autoimmune disease characterized by a breakdown of tolerance against nuclear antigens. Thanks to improvements during the last decades in diagnosis, therapeutics and medical care, the lifespan of SLE patients has remarkably increased. However, standardized mortality ratio are still high in this population, with an increased mortality and morbidity associated with cardiovascular events and infectious events. Interestingly, these conditions are more commonly found during old age in the general population, raising the question of the presence of an acceleration of the aging process in SLE patients.

It has been demonstrated that the aging of the immune system, i.e. immunosenescence, is a key player in the development of many age-related diseases. The acceleration of immunosenescence, as it is observed during chronic viral infections for example, could favor the premature occurrence of clinical manifestations of accelerated aging. The exact contribution of such phenomenon in the context of SLE has, so far, never been explored.

Here, the investigators propose to perform a comprehensive study of the phenomena of immune system aging in patients with SLE in comparison to age-matched healthy controls.

The study will recruit 50 SLE patients followed in Bordeaux University Hospital. Among classical disease activity information, blood samples will be collected at study visit to extensively evaluate immune system aging. Fundamental research will be realized on patients' samples. Patients will be included within their usual follow-up. No extra visit will be needed, and blood samples will be drawn at the same time as those drawn for clinical purposes.

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Noemie GENSOUS, MD; Phone Number: +33 (0)5 56 79 58 28; Email: noemie.gensous@chu-bordeaux.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • CHU de Bordeaux - Médecine Interne et Immunologie Clinique
    • Contact: Noemie GENSOUS, MD; Phone Number: +33 (0)5 56 79 58 28; Email: noemie.gensous@chu-bordeaux.fr
    • Principal Investigator: Noemie GENSOUS, MD
    • Sub-Investigator: Estibaliz LAZARO, Prof
    • Sub-Investigator: Christophe RICHEZ, Prof
    • Sub-Investigator: Lionel COUZI, Prof

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• male or female;
• age between 18 and 60 years;
• Lupus patient : diagnosis of systemic lupus erythematosus according to ACR or SLICC criteria;
• being affiliated to health insurance;
• willing to participate and to sign informed consent.

Exclusion Criteria:

• pregnant or breastfeeding women;
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Systemic Lupus Erythematosus; Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria	Biological: blood sample; 48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation; Biological: blood sample; blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Other: Controls; Healthy controls	Biological: blood sample; 48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation; Biological: blood sample; blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Absolute numbers of naïve T lymphocytes	At baseline (Day 0)

Secondary Outcome Measures

Outcome Measure	Time Frame
Absolute numbers of terminally differentiated T lymphocytes	At baseline (Day 0)
Percentages of terminally differentiated T lymphocytes among total lymphocytes	At baseline (Day 0)
Percentages of senescent lymphocytes among total lymphocytes	At baseline (Day 0)
Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)	At baseline (Day 0)
Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming	At baseline (Day 0)
Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement	At baseline (Day 0)
Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera	At baseline (Day 0)
Presence or absence of anti-type I interferons autoantibodies in patients sera	At baseline (Day 0)
Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)	At baseline (Day 0)
Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)	At baseline (Day 0)
Quantification of organ damage according to SLICC/ACR Damage Index	At baseline (Day 0)
Levels of anti-double stranded DNA in patients sera	At baseline (Day 0)
Levels of complement components C3 and C4 in patients sera	At baseline (Day 0)

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; University of Bordeaux
• Investigators: Principal Investigator: Noemie GENSOUS, MD, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 21, 2022
• First Submitted That Met QC Criteria: January 13, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Estimated): September 4, 2025
• Last Update Submitted That Met QC Criteria: September 3, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Systemic lupus erythematosus
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Investigative Techniques; Therapeutics; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection; Phlebotomy
• Other Study ID Numbers: CHUBX 2022/53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No