ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS

NCT ID: NCT06593041

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 450 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-09
• Study Completion Date: 2029-01-09

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.

Conditions

Systemic Lupus Erythematosus; Systemic Scleroderma Meeting; ANCA Vasculitis; Inflammatory Myositis; Gougerot-Sjögren Syndrome; Rheumatoid Arthritis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

systemic lupus erythematosus patients

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie

Strasbourg, France, France

Site Status: RECRUITING

Countries

France

Facility Contacts

Marc SCHERLINGER

Role: primary

marc.scherlinger@chru-strasbourg.fr

+33 3 88 12 79 53

Other Identifiers

8974

Identifier Type: -

Identifier Source: org_study_id