ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus, Systemic Scleroderma Meeting, ANCA Vasculitis, Inflammatory Myositis. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Phenotypic impact of platelet/immune cell interaction. [Time frame: Every visit (each 6 months) for 3 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie — Strasbourg
Identifiers
NCT: NCT06593041 · 8974