Clinical trial NCT05383339: Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
Official title: Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Autoimmune Diseases
Vasculitis
Autoinflammatory Disease
Keywords: Autoimmune Diseases
Vasculitis
Autoinflammatory Disease
disease activity biomarkers cytokine and lymphocyte profile
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2022-05-20
Enrollment: 2250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with autoimmune diseases, systemic vasculitis and/or autoinflammatory disease

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.

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.

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.

Eligibility criteria: 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

Exclusion Criteria:

* Vulnerable populations:

  * Persons deprived of liberty by judicial or administrative decision;
  * Persons receiving psychiatric care without their consent;
  * Adult subject to a legal protection measure (guardianship, curatorship);
  * Persons unable to give their consent.

Primary outcomes:
measure: Correlation between cytokine and lymphocyte profile and disease activity
timeFrame: through study completion, an average of 9 years
Secondary outcomes:
measure: Characterization of new cytokines involved in these pathologies
timeFrame: through study completion, an average of 9 years
measure: Characterization of new lymphocytes types involved in these pathologies
timeFrame: through study completion, an average of 9 years
measure: 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.)
timeFrame: through study completion, an average of 9 years
measure: Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology
timeFrame: through study completion, an average of 9 years
measure: Description of the cytokine and lymphocyte profile of each pathology.
timeFrame: through study completion, an average of 9 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Département de Médecine Interne et Immunologie Clinique (DMIIC), Hôpital Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: David Saadoun, Professor
role: PRINCIPAL_INVESTIGATOR
References: