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Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis (MICROLUPS)

Primary Purpose

Systemic Lupus Erythematosus, Systemic Scleroderma

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
blood sample
urine 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, Systemic Scleroderma, autoimmunity, microparticles, platelets

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of systemic lupus erythematosus or systemic sclerosis;
  • age ≥ 18 years;
  • being affiliated to health insurance, willing to participate and to sign informed consent.

Exclusion Criteria:

  • pregnant or breastfeeding women;
  • patient concerned by articles L 1121-5 to L 1121-8 (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 - service de rhumatologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Systemic lupus erythematosus (SLE)

systemic scleroderma (SSc)

Arm Description

Outcomes

Primary Outcome Measures

Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients

Secondary Outcome Measures

Disease activity scores for SLE patients
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Disease activity scores for SSc patients
Rodnan score
Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients
Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc

Full Information

First Posted
June 7, 2018
Last Updated
March 7, 2023
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03575156
Brief Title
Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Acronym
MICROLUPS
Official Title
Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 14, 2021 (Actual)
Study Completion Date
September 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

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
Our study aims at defining the role of circulating microparticles in the physiopathology of two rare auto-immune diseases: systemic lupus erythematosus (SLE) and systemic scleroderma (SSc). Microparticles might have an prognostic and diagnostic interest as well as potential for the discovery of new therapeutic strategies.
Detailed Description
Systemic lupus erythematosus (SLE) and systemic scleroderma (SSc) are two rare and potentially life-threatening auto-immune systemic diseases. There is an urgent need to describe prognostic factors and to discover new therapeutic pathways. Microparticles (MPs) are small extracellular vesicles formed from activated cells including endothelial cells and platelets. Preliminary data from our lab indicate that these MPs might play a key role in SLE and SSc physiopathology. In fact, MPs from patients with SLE aggregates with T regulator lymphocytes (LTregs) and decrease their activity, thereby promoting auto-immunity. Some works also indicate that MPs might cargo DNA to the immune system, also promoting auto-immunity. The investigators hypothesized that MPs levels might be a prognostic factor in SLE and SSc and that studying the molecular mechanisms involved could provide new therapeutic targets. Our study will recruit 100 patients with SLE or SSc followed in Bordeaux University Hospital. Among classical disease activity information, blood and urine samples will be collected at each visit to study circulating microparticles. Fundamental research will be realized on patients' sample to study molecular mechanisms involved. Clinical and biological disease activity, treatment and outcomes will be studied in correlation with MPs to describe their potential prognostic role. Patients will be followed at regular intervals as their usual follow-up would request. No extra visit will be needed and blood samples will be drawn at the same times 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, Systemic Scleroderma
Keywords
Systemic Lupus Erythematosus, Systemic Scleroderma, autoimmunity, microparticles, platelets

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Systemic lupus erythematosus (SLE)
Arm Type
Experimental
Arm Title
systemic scleroderma (SSc)
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
blood sample
Intervention Description
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Intervention Type
Biological
Intervention Name(s)
urine sample
Intervention Description
6 ml
Primary Outcome Measure Information:
Title
Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients
Time Frame
At baseline (Day 0) and 12 months from baseline
Secondary Outcome Measure Information:
Title
Disease activity scores for SLE patients
Description
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Time Frame
At baseline (Day 0) and 12 months from baseline
Title
Disease activity scores for SSc patients
Description
Rodnan score
Time Frame
At baseline (Day 0) and 12 months from baseline
Title
Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients
Time Frame
At baseline (Day 0) and 12 months from baseline
Title
Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc
Time Frame
At baseline (Day 0) and 12 months from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of systemic lupus erythematosus or systemic sclerosis; age ≥ 18 years; being affiliated to health insurance, willing to participate and to sign informed consent. Exclusion Criteria: pregnant or breastfeeding women; patient concerned by articles L 1121-5 to L 1121-8 (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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christophe RICHEZ, Prof
Organizational Affiliation
CHU Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux - service de rhumatologie
City
Bordeaux
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis

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