BIOMAI: Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05383339

Collaborator

Institut National de la Santé Et de la Recherche Médicale, France (Other)

2,250

Enrollment

Location

108

Anticipated Duration (Months)

20.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Diseases Vasculitis Autoinflammatory Disease	Other: Blood collection

Detailed 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.

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

Study Type:

Observational

Anticipated Enrollment :

2250 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases

Anticipated Study Start Date :

Aug 1, 2022

Anticipated Primary Completion Date :

Aug 1, 2031

Anticipated Study Completion Date :

Aug 1, 2031

Arms and Interventions

Arm	Intervention/Treatment
Patients Patients with autoimmune diseases, vasculitis and autoinflammatory diseases	Other: Blood collection - 56mL blood collected additionally to routine care

Arm

Intervention/Treatment

Patients

Patients with autoimmune diseases, vasculitis and autoinflammatory diseases

Other: Blood collection

- 56mL blood collected additionally to routine care

Outcome Measures

Primary Outcome Measures

Correlation between cytokine and lymphocyte profile and disease activity [through study completion, an average of 9 years]
Identification of new biomarkers of the activity of autoimmune diseases, systemic vasculitis and autoinflammatory diseases, using flux cytometry and ELISA analysis.

Secondary Outcome Measures

Characterization of new cytokines involved in these pathologies [through study completion, an average of 9 years]
Characterization of new cytokines involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using ELISA analysis..
Characterization of new lymphocytes types involved in these pathologies [through study completion, an average of 9 years]
Characterization of new lymphocytes types involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using flux cytometry analysis.
Correlation between the cytokine and lymphocyte profile, and the evolution of these pathologies (evolution towards mild forms, towards serious forms, death, frequency of relapses, etc.) [through study completion, an average of 9 years]
Determine predictive biomarkers of disease prognosis
Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology [through study completion, an average of 9 years]
Establish associations between different molecular subtypes, clinicohistological factors and main clinical signs.
Description of the cytokine and lymphocyte profile of each pathology. [through study completion, an average of 9 years]
Establish a molecular classification specific to each type of pathology: autoimmune diseases, systemic vasculitis and autoinflammatory diseases

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients of 18 years of age or older
Patients with autoimmune systemic disease, systemic vasculitis or autoinflammatory disease, defined by the international criteria in force for each pathology, among the following:
Connectivities: lupus, Sjögren syndrome, antiphospholipid syndrome, mixed connectivity and Sharp syndrome, scleroderma, myositis
Vasculitis of large, small and medium vessels: giant cell arteritis, Takayasu arteritis, Behçet disease, ANCA vasculitis, cryoglobulinemic vasculitis, IgA vasculitis (rheumatoid purpura)
Buerger's disease (obliterating thromboangitis)
Granulomatosis and sarcoidosis
Uveitis
Monogenic and polygenic autoinflammatory diseases: family Mediterranean fever, TRAPS, CAPS, chronic atrophic polychondritis, pericarditis
Recurrent fevers and unexplained inflammatory syndromes
Inflammatory amyloidosis
Patients affiliated to French social security