Systemic Lupus Erythematosus and Accelerated Aging

Systemic Lupus Erythematosus Clinical Trial

— LUPAGE  

Official title:

Systemic Lupus Erythematosus and Accelerated Aging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05698173
• Other study ID #: CHUBX 2022/53
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: September 2025

Study information

• Verified date: September 2023
• Source: University Hospital, Bordeaux
• Contact: Noemie GENSOUS, MD
• Phone: (0)5 56 79 58 28
• Email: noemie.gensous[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• blood sample
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
• blood sample
blood for Peripheral blood mononuclear cell (PBMC) and serum isolation

Locations

Country	Name	City	State
France	CHU de Bordeaux - Médecine Interne et Immunologie Clinique	Bordeaux

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Institut National de la Santé Et de la Recherche Médicale, France, University of Bordeaux

Country where clinical trial is conducted

France, 

Outcome

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