Clinical trial
Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
Name
CHUBX 2017/54
Description
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.
Trial arms
Trial start
2018-09-20
Estimated PCD
2021-09-14
Trial end
2021-09-14
Status
Completed
Treatment
blood sample
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
Arms:
Systemic lupus erythematosus (SLE), systemic scleroderma (SSc)
urine sample
6 ml
Arms:
Systemic lupus erythematosus (SLE), systemic scleroderma (SSc)
Size
208
Primary endpoint
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
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 208, 'type': 'ACTUAL'}}
Updated at
2023-03-08
1 organization
2 products
2 indications
Organization
University Hospital BordeauxProduct
Blood SampleIndication
Systemic Lupus ErythematosusIndication
Systemic SclerosisProduct
urine sample