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Trial record 42 of 703 for:    lupus AND Lupus Erythematosus, Systemic

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

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ClinicalTrials.gov Identifier: NCT03575156
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Systemic Scleroderma Biological: blood sample Biological: urine sample Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Arm Intervention/treatment
Experimental: Systemic lupus erythematosus (SLE) Biological: blood sample
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biological: urine sample
6 ml

Experimental: systemic scleroderma (SSc) Biological: blood sample
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation

Biological: urine sample
6 ml




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03575156


Contacts
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

Locations
France
CHU de Bordeaux - service de rhumatologie Not yet recruiting
Bordeaux, France
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   
Principal Investigator: Christophe RICHEZ, Prof         
Sub-Investigator: Marie-Elise TRUCHETET, MD, PhD         
Sub-Investigator: Lionel COUZI, Prof         
Sub-Investigator: Julien SENESCHAL, Prof         
Sub-Investigator: Pierre DUFFAU, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Christophe RICHEZ, Prof CHU - Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03575156     History of Changes
Other Study ID Numbers: CHUBX 2017/54
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: July 2, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Systemic Lupus Erythematosus
Systemic Scleroderma
autoimmunity
microparticles
platelets

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Skin Diseases