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NCT Number: NCT05698173

Systemic Lupus Erythematosus and Accelerated Aging

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - Médecine Interne et Immunologie Clinique

Bordeaux, France

Location status: Recruiting

Location contact

Christophe RICHEZ, Prof

SUB_INVESTIGATOR

Estibaliz LAZARO, Prof

SUB_INVESTIGATOR

Lionel COUZI, Prof

SUB_INVESTIGATOR

Noemie GENSOUS, MD

CONTACT

[email protected]

(0)5 56 79 58 28 ext. +33

Noemie GENSOUS, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

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

Primary outcomes

  1. Absolute numbers of naïve T lymphocytes

    Time frame: At baseline (Day 0)

Secondary outcomes

  1. Absolute numbers of terminally differentiated T lymphocytes

    Time frame: At baseline (Day 0)

  2. Percentages of terminally differentiated T lymphocytes among total lymphocytes

    Time frame: At baseline (Day 0)

  3. Percentages of senescent lymphocytes among total lymphocytes

    Time frame: At baseline (Day 0)

  4. Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)

    Time frame: At baseline (Day 0)

  5. Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming

    Time frame: At baseline (Day 0)

  6. Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement

    Time frame: At baseline (Day 0)

  7. Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera

    Time frame: At baseline (Day 0)

  8. Presence or absence of anti-type I interferons autoantibodies in patients sera

    Time frame: At baseline (Day 0)

  9. Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

    Time frame: At baseline (Day 0)

  10. Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)

    Time frame: At baseline (Day 0)

  11. Quantification of organ damage according to SLICC/ACR Damage Index

    Time frame: At baseline (Day 0)

  12. Levels of anti-double stranded DNA in patients sera

    Time frame: At baseline (Day 0)

  13. Levels of complement components C3 and C4 in patients sera

    Time frame: At baseline (Day 0)

Study contacts

Contact information is provided by the study sponsor or research team.

Noemie GENSOUS, MD

CONTACT

[email protected]

(0)5 56 79 58 28 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Collaborators

  • Institut National de la Santé Et de la Recherche Médicale, France
  • University of Bordeaux

Registry information

Acronym: LUPAGE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2023
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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