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Completed

NCT Number: NCT03575156

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux - service de rhumatologie

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Blood sample

Biological

36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

urine sample

Biological

6 ml

Primary outcomes

  1. 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 outcomes

  1. Disease activity scores for SLE patients

    Time frame: At baseline (Day 0) and 12 months from baseline

    Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)

  2. Disease activity scores for SSc patients

    Time frame: At baseline (Day 0) and 12 months from baseline

    Rodnan score

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: MICROLUPS

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 2, 2018
Registry last updated
May 14, 2026

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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