Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis (MICROLUPS)
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| ClinicalTrials.gov Identifier: NCT03575156 |
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Recruitment Status :
Recruiting
First Posted : July 2, 2018
Last Update Posted : October 3, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Systemic Lupus Erythematosus Systemic Scleroderma | Biological: blood sample Biological: urine sample | Not Applicable |
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 |
| Actual Study Start Date : | September 20, 2018 |
| Estimated Primary Completion Date : | September 2021 |
| Estimated Study Completion Date : | September 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 |
- 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 ]
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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)
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
| 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 |
| France | |
| CHU de Bordeaux - service de rhumatologie | 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 | |
| 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: | October 3, 2018 |
| Last Verified: | October 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 |
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Systemic Lupus Erythematosus Systemic Scleroderma autoimmunity microparticles platelets |
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Lupus Erythematosus, Systemic Scleroderma, Systemic Scleroderma, Diffuse Connective Tissue Diseases |
Autoimmune Diseases Immune System Diseases Skin Diseases |