ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS

NCT06593041 | Recruiting

• 1 other identifier: 8974
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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

Keywords

PLATELETS; PATHOPHYSIOLOGY; SYSTEMIC LUPUS

Outcome Measures

Primary Outcomes (1)

• The primary endpoint will be the percentage of circulating aggregates between platelets and immune cells according to disease activity, assessed by flow cytometry.

  Every visit for 3 years

Secondary Outcomes (1)

• Phenotypic impact of platelet/immune cell interaction.

  Every visit (each 6 months) for 3 years

Other Outcomes (3)

• Transcriptomic impact of platelet/immune cell interaction.

  Every visit (each 6 months) for 3 years

• Measurement of biomarkers of disease activity / predictive of disease flare-ups.

  Every visit (each 6 months) for 3 years

• Identification of genetic polymorphisms

  Every visit (each 6 months) for 3 years

Study Arms (1)

systemic lupus erythematosus patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)
• Patient under court protection
• Patient under guardianship or curatorship

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, France, 67098, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood samples: For each biological check-up carried out as part of routine care, or in case of flare, an additional 25 mL will be punctured for research purposes, if the patient's condition allows. * Tissue samples (skin biopsy, kidney biopsy, synovial biopsy and accessory salivary gland biopsy) + Joint, pleural, alveolar and pericardial fluid samples: Remains will be requalified as research if the remaining quantity allows.

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: January 9, 2024
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): January 9, 2029
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

FR (1)