Clinical trial NCT06593041: ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
Official title: ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Systemic Scleroderma Meeting
ANCA Vasculitis
Inflammatory Myositis
Gougerot-Sjögren Syndrome
Rheumatoid Arthritis
Keywords: PLATELETS
PATHOPHYSIOLOGY
SYSTEMIC LUPUS
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with systemic auto-immune disease such as :

* Systemic lupus
* Anca-associated vasculitis
* Sjögren's disease
* Rheumatoid arthritis
* Systemic sclerosis

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

Primary outcomes:
measure: The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.
timeFrame: Every visit for 3 years
Secondary outcomes:
measure: Phenotypic impact of platelet/immune cell interaction.
timeFrame: Every visit (each 6 months) for 3 years
Other outcomes:
measure: Transcriptomic impact of platelet/immune cell interaction.
timeFrame: Every visit (each 6 months) for 3 years
measure: Measurement of biomarkers of disease activity / predictive of disease flare-ups.
timeFrame: Every visit (each 6 months) for 3 years
measure: Identification of genetic polymorphisms
timeFrame: Every visit (each 6 months) for 3 years
Locations:
city: Strasbourg
country: France
facility: Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie
Study officials:
References: