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NCT06593041Recruiting

ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS

Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
450 (estimated)
First submitted
4 Sept 2024
Start date
9 Jan 2024
Primary completion date
9 Feb 2027
Lead sponsor
University Hospital, Strasbourg, France
NCT number
NCT06593041

What you commit to

  • Study type: Observational
  • Planned participants: 450
  • From 9 Jan 2024 to the primary completion date, 9 Feb 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patient in exclusion period (determined by a previous or current study)

Other

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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre - Service de rhumatologie
Coordinator of this site? Confirm its status
StrasbourgFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.