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Clinical Trial Summary

The objective of this work is to identify, in patients with autoimmune diseases, systemic vasculitis and autoinflammatory disease, cytokine and lymphocyte biomarkers of activity of these diseases to identify follow-up biomarkers, in order to personalize the follow-up and the treatments for each patient. Immunological data will be obtained from biological samples collected as part of the usual patient care pathway (Blood and tissues sampling) The study will take place in the Department of Internal Medicine and Clinical Immunology (DMIIC), that is certified as the National Reference Centre for Rare Systemic Autoimmune Diseases and the National Reference Centre for Inflammatory Autoinflammatory Diseases and Inflammatory Amyloidosis (CEREMAIA). Its objective is to contribute to the advancement of fundamental knowledge in immunology, in particular to develop prognostic biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases by using blood tests.


Clinical Trial Description

Autoimmune systemic diseases, systemic vasculitis and autoinflammatory diseases are diseases involving the innate and adaptive immune systems. The pro and anti-inflammatory cytokines, and the T and B lymphocytes appear as key actors of these pathologies, at the interface between the innate and adaptive immune system. The evolutionary profile of patients is highly variable, with some patients with minor forms mainly affecting the skin and joints for example, and others with potentially serious organ damage (e.g., renal involvement in lupus or vasculitis). At this time, we do not have markers to identify patients who will exhibit severe forms. Besides, treatments have evolved a lot over the years and mainly aime at controlling inflammation, either through non-target treatments (conventional immunosuppressants) or targeted biotherapies (anti-TNF, anti-interleukin 6, etc.). However, these treatments have in common to be suspensive in the majority of cases and the systemic diseases described tend to relapse frequently without clearly identifying clinical or biological factors predicting relapse. Patients are therefore exposed to treatments with many short-, medium- and long-term side effects without being able to identify precisely which patients benefit and which patients do not need further treatment. The objective of this work is to identify, in patients with autoimmune diseases, systemic vasculitis and autoinflammatory disease, cytokine and lymphocyte biomarkers of activity of these diseases to identify follow-up biomarkers, in order to personalize the follow-up and the treatments for each patient. Immunological data will be obtained from biological samples collected as part of the usual patient care pathway (Blood samples and tissues sampling) The Department of Internal Medicine and Clinical Immunology (DMIIC) is certified as the National Reference Centre for Rare Systemic Autoimmune Diseases and the National Reference Centre for Inflammatory Autoinflammatory Diseases and Inflammatory Amyloidosis (CEREMAIA). It has a fundamental research laboratory dedicated to the immunology of translational systems. Its objective is to contribute to the advancement of fundamental knowledge in immunology and in particular to develop prognostic biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases by using blood tests. Several thousand patients with various autoimmune and autoinflammatory diseases are followed in the DMIIC, making the Department particularly suitable for this type of research. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05383339
Study type Observational
Source Assistance Publique - Hôpitaux de Paris
Contact David Saadoun, Professor
Phone +33142161051
Email david.saadoun@aphp.fr
Status Recruiting
Phase
Start date November 29, 2022
Completion date November 29, 2031

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