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Systemic Lupus Erythematosus and Accelerated Aging

Systemic Lupus Erythematosus and Accelerated Aging

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05698173
Acronym
LUPAGE
Enrollment
75
Registered
2023-01-26
Start date
2023-09-08
Completion date
2026-09-30
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic lupus erythematosus, Aging

Brief summary

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

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.

Interventions

BIOLOGICALblood sample

48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

Sponsors

University of Bordeaux
CollaboratorOTHER
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Absolute numbers of naïve T lymphocytesAt baseline (Day 0)

Secondary

MeasureTime frame
Percentages of terminally differentiated T lymphocytes among total lymphocytesAt baseline (Day 0)
Percentages of senescent lymphocytes among total lymphocytesAt 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 primingAt baseline (Day 0)
Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurementAt baseline (Day 0)
Concentrations of senescence-associated secretory phenotype (SASP) markers in patients seraAt baseline (Day 0)
Absolute numbers of terminally differentiated T lymphocytesAt 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 IndexAt baseline (Day 0)
Levels of anti-double stranded DNA in patients seraAt baseline (Day 0)
Levels of complement components C3 and C4 in patients seraAt baseline (Day 0)
Presence or absence of anti-type I interferons autoantibodies in patients seraAt baseline (Day 0)

Countries

France

Contacts

Primary ContactNoemie GENSOUS, MD
noemie.gensous@chu-bordeaux.fr(0)5 56 79 58 28

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026