Systemic Lupus ErythematosusPLAQUETTOLUPNCT06593041
ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
An observational study of Systemic Lupus Erythematosus and Systemic Scleroderma Meeting, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Scleroderma Meeting, ANCA Vasculitis
- How many people
- 450 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jan 2024to 9 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with systemic auto-immune disease such as : * Systemic lupus * Anca-associated vasculitis * Sjögren's disease * Rheumatoid arthritis * Systemic sclerosis
Who may be able to join
- Patients between 18 and 70 years of age
- Patient affiliated to a health insurance scheme (beneficiary or beneficiary's beneficiary)
- Patient able to understand the aims and risks of research
- Patient having signed and dated an informed consent form
- Patient for whom the diagnosis of at least one of the following pathologies has been confirmed:
- Systemic lupus erythematosus meeting ACR/EULAR 20195 classification criteria.
Show all 11Show fewer
- Systemic scleroderma meeting ACR/EULAR 20136 classification criteria.
- ANCA vasculitis according to EULAR/ACR 2022.7-9 classification criteria.
- Inflammatory myositis according to EULAR/ACR 201710 classification criteria.
- Gougerot-Sjögren syndrome according to EULAR/ACR 2016 classification criteria11.
- Rheumatoid arthritis according to ACR/EULAR 201012 classification criteria.
Who cannot join
- Patient in exclusion period (determined by a previous or current study)
- Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)
- Patient under court protection
- Patient under guardianship or curatorship
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie
Strasbourg, France, 67098
Marc SCHERLINGER, +33 3 88 12 79 53, marc.scherlinger@chru-strasbourg.fr
About this study
Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Once activated, platelets express adhesion molecules such as P-selectin on their surface, enabling them to interact physically with immune cells. In a recent work, we identified that activated platelets from lupus patients interact with regulatory T cells and block their regulatory function, thus participating in the deregulated activation of the immune system in SLE. In addition, inhibition of platelet-immune cell interactions by an anti-P-selectin antibody improved LES symptoms in two mouse models.
The aim of this work is to investigate other potential platelet-immune cell interactions in patients with SLE, in comparison with other autoimmune diseases (systemic scleroderma, ANCA vasculitides, inflammatory myositis, Gougerot-Sjögren syndrome and rheumatoid arthritis).
This study could lead to a better understanding of the role of platelets in the pathophysiology of autoimmune diseases, identify new biomarkers of activity, and assess the potential of new therapeutic avenues in these diseases, such as platelet targeting.
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma Meeting, ANCA Vasculitis, Inflammatory Myositis, Gougerot-Sjögren Syndrome, Rheumatoid Arthritis
- Keywords
- PLATELETS, PATHOPHYSIOLOGY, SYSTEMIC LUPUS
- Medical subject headings
- Lupus Erythematosus, Systemic, Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| systemic lupus erythematosus patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.
Measured: Every visit for 3 years
Secondary outcomes (1)
Phenotypic impact of platelet/immune cell interaction.
The impact of platelet/immune cell interaction will be assessed using flow cytometry on patient samples. Using a spectral cytometer (Aurora, Cytek) and a multi-color panel (45 colors), we will study the phenotype and degree of activation of different immune subpopulations according to whether or not they interact with platelets. This analysis will be carried out several times during the different visits, and mirrored with the disease activity criteria studied. Activation molecule expression will be analyzed using the same methods as for the main criterion (comparison of the patient with himself/herself using longitudinal samples).
Measured: Every visit (each 6 months) for 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start9 Jan 2024
- Primary completion9 Feb 2027 (estimated)
- Study completion9 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06593041
- Sponsor's protocol ID
- 8974
- Acronym
- PLAQUETTOLUP
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
- ClinicalTrials.gov ID
- NCT06593041
- Acronym / sponsor ID
- PLAQUETTOLUP / 8974
- Conditions
- Systemic Lupus Erythematosus, Systemic Scleroderma Meeting, ANCA Vasculitis, Inflammatory Myositis, Gougerot-Sjögren Syndrome, Rheumatoid Arthritis
- Keywords
- PLATELETS, PATHOPHYSIOLOGY, SYSTEMIC LUPUS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 9 Jan 2024 (actual)
- Primary completion
- 9 Feb 2027 (estimated)
- Study completion
- 9 Jan 2029 (estimated)
- First posted
- 19 Sep 2024 (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.
Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Once activated, platelets express adhesion molecules such as P-selectin on their surface, enabling them to interact physically with immune cells. In a recent work, we identified that activated platelets from lupus patients interact with regulatory T cells and block their regulatory function, thus participating in the deregulated activation of the immune system in SLE. In addition, inhibition of platelet-immune cell interactions by an anti-P-selectin antibody improved LES symptoms in two mouse models.
The aim of this work is to investigate other potential platelet-immune cell interactions in patients with SLE, in comparison with other autoimmune diseases (systemic scleroderma, ANCA vasculitides, inflammatory myositis, Gougerot-Sjögren syndrome and rheumatoid arthritis).
This study could lead to a better understanding of the role of platelets in the pathophysiology of autoimmune diseases, identify new biomarkers of activity, and assess the potential of new therapeutic avenues in these diseases, such as platelet targeting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| systemic lupus erythematosus patients | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic auto-immune disease such as : * Systemic lupus * Anca-associated vasculitis * Sjögren's disease * Rheumatoid arthritis * Systemic sclerosis
Key inclusion criteria (11 listed)
- Patients between 18 and 70 years of age
- Patient affiliated to a health insurance scheme (beneficiary or beneficiary's beneficiary)
- Patient able to understand the aims and risks of research
- Patient having signed and dated an informed consent form
- Patient for whom the diagnosis of at least one of the following pathologies has been confirmed:
Key exclusion criteria (4 listed)
- Patient in exclusion period (determined by a previous or current study)
- Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)
- Patient under court protection
- Patient under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.
Time frame: Every visit for 3 years
1 secondary outcome
Phenotypic impact of platelet/immune cell interaction.
Time frame: Every visit (each 6 months) for 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
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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.
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus and Systemic Scleroderma Meeting, run by University Hospital, Strasbourg, France 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 11 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry. (time frame: Every visit for 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2024.