Systemic Lupus ErythematosusMICROLUPSNCT03575156
Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
A study testing blood sample and urine sample in people with Systemic Lupus Erythematosus and Systemic Scleroderma, run by University Hospital, Bordeaux at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Scleroderma
- What is being tested?
- blood sample and urine sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2018to 14 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of systemic lupus erythematosus or systemic sclerosis;
- age ≥ 18 years;
- being affiliated to health insurance, willing to participate and to sign informed consent.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma
- Being tested
- blood sample, urine sample
- Keywords
- Systemic Lupus Erythematosus, Systemic Scleroderma, autoimmunity, microparticles, platelets
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampleBiological
36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
urine sampleBiological
6 ml
| Study group | Role | What they receive |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Not described Receives: Biological: blood sample; Biological: urine sample |
| systemic scleroderma (SSc) | Experimental | Not described Receives: Biological: blood sample; Biological: urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in quantitative levels of circulating MPs between baseline and 12 months in the blood and urine samples of SLE and SSc patients
Measured: At baseline (Day 0) and 12 months from baseline
Secondary outcomes (4)
Disease activity scores for SLE patients
Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: At baseline (Day 0) and 12 months from baseline
Disease activity scores for SSc patients
Rodnan score
Measured: At baseline (Day 0) and 12 months from baseline
Quantification of P-selectin levels (soluble and on platelets) in the blood and urine samples of SLE and SSc patients
Measured: At baseline (Day 0) and 12 months from baseline
Quantification of FAS-ligand levels in the blood and urine samples of SLE and SSc
Measured: At baseline (Day 0) and 12 months from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start20 Sep 2018
- Primary completion14 Sep 2021
- Study completion14 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christophe RICHEZ, Prof, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03575156
- Sponsor's protocol ID
- CHUBX 2017/54
- Other IDs
- 2018-A00599-46
- Acronym
- MICROLUPS
- Status last verified
- Mar 2023
- First submitted
- 7 Jun 2018
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leleu D, Levionnois E, Laurent P, Lazaro E, Richez C, Duffau P, Blanco P, Sisirak V, Contin-Bordes C, Truchetet ME. Elevated Circulatory Levels of Microparticles Are Associated to Lung Fibrosis and Vasculopathy During Systemic Sclerosis. Front Immunol. 2020 Oct 23;11:532177. doi: 10.3389/fimmu.2020.532177. eCollection 2020.
PubMed 33193304Scherlinger M, Guillotin V, Douchet I, Vacher P, Boizard-Moracchini A, Guegan JP, Garreau A, Merillon N, Vermorel A, Ribeiro E, Machelart I, Lazaro E, Couzi L, Duffau P, Barnetche T, Pellegrin JL, Viallard JF, Saleh M, Schaeverbeke T, Legembre P, Truchetet ME, Dumortier H, Contin-Bordes C, Sisirak V, Richez C, Blanco P. Selectins impair regulatory T cell function and contribute to systemic lupus erythematosus pathogenesis. Sci Transl Med. 2021 Jun 30;13(600):eabi4994. doi: 10.1126/scitranslmed.abi4994.
PubMed 34193612
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microparticles's Role in the Pathophysiology of Systemic Lupus Erythematosus and Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT03575156
- Acronym / sponsor ID
- MICROLUPS / CHUBX 2017/54
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma
- Keywords
- Systemic Lupus Erythematosus, Systemic Scleroderma, autoimmunity, microparticles, platelets
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 14 Sep 2021 (actual)
- First posted
- 2 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic lupus erythematosus (SLE) | Experimental | Biological: blood sample, Biological: urine sample |
| systemic scleroderma (SSc) | Experimental | Biological: blood sample, Biological: urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- diagnosis of systemic lupus erythematosus or systemic sclerosis;
- age ≥ 18 years;
- being affiliated to health insurance, willing to participate and to sign informed consent.
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation | Biological | Systemic lupus erythematosus (SLE), systemic scleroderma (SSc) |
| urine sample6 ml | Biological | Systemic lupus erythematosus (SLE), systemic scleroderma (SSc) |
Primary outcome
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
4 secondary outcomes
Disease activity scores for SLE patients
Time frame: At baseline (Day 0) and 12 months from baseline
Disease activity scores for SSc patients
Time frame: At baseline (Day 0) and 12 months from baseline
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 33193304Leleu D, Levionnois E, Laurent P, Lazaro E, Richez C, Duffau P, Blanco P, Sisirak V, Contin-Bordes C, Truchetet ME. Elevated Circulatory Levels of Microparticles Are Associated to Lung Fibrosis and Vasculopathy During Systemic Sclerosis. Front Immunol. 2020 Oct 23;11:532177. doi: 10.3389/fimmu.2020.532177. eCollection 2020.
- Results publication: PubMed 34193612Scherlinger M, Guillotin V, Douchet I, Vacher P, Boizard-Moracchini A, Guegan JP, Garreau A, Merillon N, Vermorel A, Ribeiro E, Machelart I, Lazaro E, Couzi L, Duffau P, Barnetche T, Pellegrin JL, Viallard JF, Saleh M, Schaeverbeke T, Legembre P, Truchetet ME, Dumortier H, Contin-Bordes C, Sisirak V, Richez C, Blanco P. Selectins impair regulatory T cell function and contribute to systemic lupus erythematosus pathogenesis. Sci Transl Med. 2021 Jun 30;13(600):eabi4994. doi: 10.1126/scitranslmed.abi4994.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingPhase 4
Dapagliflozin in Active Lupus Nephritis
Lupus Nephritis (LN)
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christophe RICHEZ, Prof principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and urine sample in people with Systemic Lupus Erythematosus and Systemic Scleroderma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03575156, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.