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

Systemic Lupus Erythematosus Clinical Trial

— MICROLUPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575156
• Other study ID #: CHUBX 2017/54
• Status: Completed
• Phase: N/A
• Start date: September 20, 2018
• Est. completion date: September 14, 2021

Study information

• Verified date: March 2023
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 14, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Scleroderma, Diffuse
• Scleroderma, Systemic
• Systemic Lupus Erythematosus
• Systemic Scleroderma

Intervention

Biological:
• blood sample
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
• urine sample
6 ml

Locations

Country	Name	City	State
France	CHU de Bordeaux - service de rhumatologie	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients		At baseline (Day 0) and 12 months from baseline
Secondary	Disease activity scores for SLE patients	Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)	At baseline (Day 0) and 12 months from baseline
Secondary	Disease activity scores for SSc patients	Rodnan score	At baseline (Day 0) and 12 months from baseline
Secondary	Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients		At baseline (Day 0) and 12 months from baseline
Secondary	Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc		At baseline (Day 0) and 12 months from baseline