search
Back to results

Systemic Lupus Erythematosus and Accelerated Aging (LUPAGE)

Primary Purpose

Systemic Lupus Erythematosus

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
blood sample
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Systemic Lupus Erythematosus focused on measuring Systemic lupus erythematosus, Aging

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Bordeaux - Médecine Interne et Immunologie CliniqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Systemic Lupus Erythematosus

Controls

Arm Description

Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria

Healthy controls

Outcomes

Primary Outcome Measures

Absolute numbers of naïve T lymphocytes

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2022
Last Updated
September 11, 2023
Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT05698173
Brief Title
Systemic Lupus Erythematosus and Accelerated Aging
Acronym
LUPAGE
Official Title
Systemic Lupus Erythematosus and Accelerated Aging
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 8, 2023 (Actual)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
Collaborators
University of Bordeaux, Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic lupus erythematosus, Aging

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Systemic Lupus Erythematosus
Arm Type
Experimental
Arm Description
Diagnosis of systemic lupus erythematosus according to American College of Rheumatology (ACR) or SLICC criteria
Arm Title
Controls
Arm Type
Other
Arm Description
Healthy controls
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
48 ml whole blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
blood for Peripheral blood mononuclear cell (PBMC) and serum isolation
Primary Outcome Measure Information:
Title
Absolute numbers of naïve T lymphocytes
Time Frame
At baseline (Day 0)
Secondary Outcome Measure Information:
Title
Absolute numbers of terminally differentiated T lymphocytes
Time Frame
At baseline (Day 0)
Title
Percentages of terminally differentiated T lymphocytes among total lymphocytes
Time Frame
At baseline (Day 0)
Title
Percentages of senescent lymphocytes among total lymphocytes
Time Frame
At baseline (Day 0)
Title
Telomere length in sorted CD4+ and CD8+ T lymphocytes subsets (naïve and memory)
Time Frame
At baseline (Day 0)
Title
Frequency and phenotype of ELA-specific CD8+ T-cells after 10 days of in vitro priming
Time Frame
At baseline (Day 0)
Title
Number of naïve T lymphocytes newly produced by thymus evaluated by T-cell receptor excision circles (TRECs) measurement
Time Frame
At baseline (Day 0)
Title
Concentrations of senescence-associated secretory phenotype (SASP) markers in patients sera
Time Frame
At baseline (Day 0)
Title
Presence or absence of anti-type I interferons autoantibodies in patients sera
Time Frame
At baseline (Day 0)
Title
Measurement of disease activity according to Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time Frame
At baseline (Day 0)
Title
Measurement of disease activity according to British Lupus Assessment Group Index 2004 (BILAG-2004)
Time Frame
At baseline (Day 0)
Title
Quantification of organ damage according to SLICC/ACR Damage Index
Time Frame
At baseline (Day 0)
Title
Levels of anti-double stranded DNA in patients sera
Time Frame
At baseline (Day 0)
Title
Levels of complement components C3 and C4 in patients sera
Time Frame
At baseline (Day 0)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Noemie GENSOUS, MD
Phone
(0)5 56 79 58 28
Ext
+33
Email
noemie.gensous@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noemie GENSOUS, MD
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - Médecine Interne et Immunologie Clinique
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Noemie GENSOUS, MD
Phone
(0)5 56 79 58 28
Ext
+33
Email
noemie.gensous@chu-bordeaux.fr
First Name & Middle Initial & Last Name & Degree
Noemie GENSOUS, MD
First Name & Middle Initial & Last Name & Degree
Christophe RICHEZ, Prof
First Name & Middle Initial & Last Name & Degree
Lionel COUZI, Prof
First Name & Middle Initial & Last Name & Degree
Estibaliz LAZARO, Prof

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Systemic Lupus Erythematosus and Accelerated Aging

We'll reach out to this number within 24 hrs