Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03575156
Recruitment Status : Recruiting
First Posted : July 2, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE June 7, 2018
First Posted Date  ICMJE July 2, 2018
Last Update Posted Date October 3, 2018
Actual Study Start Date  ICMJE September 20, 2018
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03575156 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2018)
  • Disease activity scores for SLE patients [ Time Frame: At baseline (Day 0) and 12 months from baseline ]
    Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
  • Disease activity scores for SSc patients [ Time Frame: At baseline (Day 0) and 12 months from baseline ]
    Rodnan score
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Official Title  ICMJE Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Systemic Lupus Erythematosus
  • Systemic Scleroderma
Intervention  ICMJE
  • Biological: blood sample
    36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
  • Biological: urine sample
    6 ml
Study Arms  ICMJE
  • Experimental: Systemic lupus erythematosus (SLE)
    Interventions:
    • Biological: blood sample
    • Biological: urine sample
  • Experimental: systemic scleroderma (SSc)
    Interventions:
    • Biological: blood sample
    • Biological: urine sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2018)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2021
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christophe RICHEZ, Prof (0)5 56 79 55 56 ext +33 christophe.richez@chu-bordeaux.fr
Contact: Thomas BARNETCHE, PhD (0)5.57.82.04.93 ext +33 thomas.barnetche@chu-bordeaux.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03575156
Other Study ID Numbers  ICMJE CHUBX 2017/54
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Bordeaux
Study Sponsor  ICMJE University Hospital, Bordeaux
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christophe RICHEZ, Prof CHU - Bordeaux
PRS Account University Hospital, Bordeaux
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP