NCT06593041 ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
| NCT ID | NCT06593041 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Strasbourg, France |
| Condition | Systemic Lupus Erythematosus |
| Study Type | OBSERVATIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-01-09 |
| Primary Completion | 2027-02-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 450 participants in total. It began in 2024-01-09 with a primary completion date of 2027-02-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
Inclusion Criteria: * 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. * 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. Exclusion Criteria: * 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
Frequently Asked Questions
Who can join the NCT06593041 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Systemic Lupus Erythematosus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06593041 currently recruiting?
Yes, NCT06593041 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Strasbourg, France to inquire about joining.
Where is the NCT06593041 trial being conducted?
This trial is being conducted at Strasbourg, France.
Who is sponsoring the NCT06593041 clinical trial?
NCT06593041 is sponsored by University Hospital, Strasbourg, France. The trial plans to enroll 450 participants.
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