Systemic Lupus ErythematosusLUPAGENCT05698173
Systemic Lupus Erythematosus and Accelerated Aging
A study testing blood sample in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 8 Sep 2023to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux - Médecine Interne et Immunologie Clinique
Bordeaux
Noemie GENSOUS, MD, (0)5 56 79 58 28 ext. +33, noemie.gensous@chu-bordeaux.fr
Noemie GENSOUS, MD
About this study
The study aims at evaluating the phenomena of immune system aging in patients with Systemic lupus erythematosus.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- blood sample
- Keywords
- Systemic lupus erythematosus, Aging
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
blood sampleBiological
blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
| Study group | Role | What they receive |
|---|---|---|
| Systemic Lupus Erythematosus | Experimental | Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria Receives: Biological: blood sample |
| Controls | Other | Healthy controls Receives: Biological: blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute numbers of naïve T lymphocytes
Measured: At baseline (Day 0)
Secondary outcomes (13)
Absolute numbers of terminally differentiated T lymphocytes
Measured: At baseline (Day 0)
Percentages of terminally differentiated T lymphocytes among total lymphocytes
Measured: At baseline (Day 0)
Percentages of senescent lymphocytes among total lymphocytes
Measured: At baseline (Day 0)
Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)
Measured: At baseline (Day 0)
Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming
Measured: At baseline (Day 0)
Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement
Measured: At baseline (Day 0)
Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera
Measured: At baseline (Day 0)
Presence or absence of anti-type I interferons autoantibodies in patients sera
Measured: At baseline (Day 0)
Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: At baseline (Day 0)
Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
Measured: At baseline (Day 0)
Quantification of organ damage according to SLICC/ACR Damage Index
Measured: At baseline (Day 0)
Levels of anti-double stranded DNA in patients sera
Measured: At baseline (Day 0)
Levels of complement components C3 and C4 in patients sera
Measured: At baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start8 Sep 2023
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Noemie GENSOUS, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05698173
- Sponsor's protocol ID
- CHUBX 2022/53
- Acronym
- LUPAGE
- Status last verified
- Sep 2025
- First submitted
- 21 Dec 2022
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Lupus Erythematosus and Accelerated Aging
- ClinicalTrials.gov ID
- NCT05698173
- Acronym / sponsor ID
- LUPAGE / CHUBX 2022/53
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic lupus erythematosus, Aging
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 26 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Lupus Erythematosus | Experimental | Biological: blood sampleDiagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria |
| Controls | Other | Biological: blood sampleHealthy controls |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation | Biological | Systemic Lupus Erythematosus |
| blood sampleblood for Peripheral blood mononuclear cell (PBMC) and serum isolation | Biological | Controls |
Primary outcome
Absolute numbers of naïve T lymphocytes
Time frame: At baseline (Day 0)
13 secondary outcomes
Absolute numbers of terminally differentiated T lymphocytes
Time frame: At baseline (Day 0)
Percentages of terminally differentiated T lymphocytes among total lymphocytes
Time frame: At baseline (Day 0)
Percentages of senescent lymphocytes among total lymphocytes
Time frame: At baseline (Day 0)
Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)
Time frame: At baseline (Day 0)
Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming
Time frame: At baseline (Day 0)
Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement
Time frame: At baseline (Day 0)
Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera
Time frame: At baseline (Day 0)
Presence or absence of anti-type I interferons autoantibodies in patients sera
Time frame: At baseline (Day 0)
Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time frame: At baseline (Day 0)
Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
Time frame: At baseline (Day 0)
Quantification of organ damage according to SLICC/ACR Damage Index
Time frame: At baseline (Day 0)
Levels of anti-double stranded DNA in patients sera
Time frame: At baseline (Day 0)
Levels of complement components C3 and C4 in patients sera
Time frame: At baseline (Day 0)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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Pakistan Arthritis and Connective Tissue Disease Network - Systemic Lupus Erythematosus
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noemie GENSOUS, MD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample in people with Systemic Lupus Erythematosus, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemie GENSOUS, MD ((0)5 56 79 58 28 ext. +33, noemie.gensous@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute numbers of naïve T lymphocytes (time frame: At baseline (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2025.