Clinical trial NCT05698173: Systemic Lupus Erythematosus and Accelerated Aging
Official title: Systemic Lupus Erythematosus and Accelerated Aging
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic lupus erythematosus
Aging
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: University of Bordeaux
name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2023-01-26
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Absolute numbers of naïve T lymphocytes
timeFrame: At baseline (Day 0)
Secondary outcomes:
measure: Absolute numbers of terminally differentiated T lymphocytes
timeFrame: At baseline (Day 0)
measure: Percentages of terminally differentiated T lymphocytes among total lymphocytes
timeFrame: At baseline (Day 0)
measure: Percentages of senescent lymphocytes among total lymphocytes
timeFrame: At baseline (Day 0)
measure: Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)
timeFrame: At baseline (Day 0)
measure: Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming
timeFrame: At baseline (Day 0)
measure: Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement
timeFrame: At baseline (Day 0)
measure: Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera
timeFrame: At baseline (Day 0)
measure: Presence or absence of anti-type I interferons autoantibodies in patients sera
timeFrame: At baseline (Day 0)
measure: Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
timeFrame: At baseline (Day 0)
measure: Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
timeFrame: At baseline (Day 0)
measure: Quantification of organ damage according to SLICC/ACR Damage Index
timeFrame: At baseline (Day 0)
measure: Levels of anti-double stranded DNA in patients sera
timeFrame: At baseline (Day 0)
measure: Levels of complement components C3 and C4 in patients sera
timeFrame: At baseline (Day 0)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux - Médecine Interne et Immunologie Clinique
Study officials:
affiliation: University Hospital, Bordeaux
name: Noemie GENSOUS, MD
role: PRINCIPAL_INVESTIGATOR
References: