Microparticles's Role in the Pathophysiology of Systemic Lupus

Status Completed

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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03575156
Study type	Interventional
Source	University Hospital, Bordeaux
Contact
Status	Completed
Phase	N/A
Start date	September 20, 2018
Completion date	September 14, 2021

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT03843125` - A Study of Baricitinib in Participants With Systemic Lupus Erythematosus (SLE)	Phase 3
Recruiting	`NCT05698173` - Systemic Lupus Erythematosus and Accelerated Aging	N/A
Active, not recruiting	`NCT01649765` - Pediatric Lupus Trial of Belimumab Plus Background Standard Therapy	Phase 2
Recruiting	`NCT05704153` - Modelling and Control of Non-invasive Vagus Nerve Stimulation for Autoimmune Diseases (1A)	N/A
Completed	`NCT05048238` - Evaluation of Tofacitinib in Prevention of Photosensitivity in Lupus	Phase 1
Recruiting	`NCT06056778` - The Prevalence Evaluation of Systemic Lupus Erythematosus in Russian Patients With Reproductive Issues (PRISMA)
Completed	`NCT04358302` - Individual Patient Exposure and Response in Pediatric Lupus	N/A
Completed	`NCT03802578` - The Impact of Exercise on Hand Function, Daily Activities Performance and Quality of Life of SLE' Patients	N/A
Completed	`NCT02554019` - Proof-of-Concept Study With BT063 in Subjects With Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT04835883` - Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients	Phase 2
Terminated	`NCT02665364` - Phase IIb Study of IFN-K in Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00278538` - Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus	Phase 2
Completed	`NCT00069342` - Health Beliefs and Health Behaviors Among Minorities With Rheumatic Diseases
Completed	`NCT03252587` - An Investigational Study to Evaluate BMS-986165 in Participants With Systemic Lupus Erythematosus	Phase 2
Terminated	`NCT02066311` - Nelfinavir in Systemic Lupus Erythematosus	Phase 2
Recruiting	`NCT01892748` - Cholecalciferol Supplementation on Disease Activity, Fatigue and Bone Mass on Juvenile Systemic Lupus Erythematosus.	N/A
Terminated	`NCT01689025` - An Investigation of Safety and Tolerability of NNC0114-0006 in Subjects With Systemic Lupus Erythematosus (SLE)	Phase 1
Completed	`NCT01475149` - Effect of HCQ on AnxA5 Resistance Assay in Antiphospholipid (aPL) Positive Patients With and Without Systemic Lupus Erythematosus (SLE)	N/A
Unknown status	`NCT01712529` - Physical Exercise, Endothelial Function and Progenitor Endothelial Cells in Systemic Lupus Erythematosus Patients	N/A
Completed	`NCT00962832` - A Study to Evaluate the Efficacy and Safety of Rontalizumab in Patients With Moderately to Severely Active Systemic Lupus Erythematosus	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms