Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases (BIOMAI)

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.

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases; Vasculitis; Autoinflammatory Disease
• Intervention / Treatment: 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.

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 Type: Observational
• Enrollment (Estimated): 2250

Contacts and Locations

• Study Contact: Name: David Saadoun, Professor; Phone Number: +33142161051; Email: david.saadoun@aphp.fr
• Study Contact Backup: Name: Nassima Mansour; Phone Number: +33184828101; Email: nassima.mansour@aphp.fr

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Département de Médecine Interne et Immunologie Clinique (DMIIC), Hôpital Pitié-Salpêtrière
    • Contact: David Saadoun, Professor; Phone Number: +33142161051; Email: david.saadoun@aphp.fr
    • Contact: Nassima Mansour; Phone Number: +33184828101; Email: nassima.mansour@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with autoimmune diseases, systemic vasculitis and/or autoinflammatory disease

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterization of new cytokines involved in these pathologies	Characterization of new cytokines involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using ELISA analysis..	through study completion, an average of 9 years
Characterization of new lymphocytes types involved in these pathologies	Characterization of new lymphocytes types involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using flux cytometry analysis.	through study completion, an average of 9 years
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.)	Determine predictive biomarkers of disease prognosis	through study completion, an average of 9 years
Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology	Establish associations between different molecular subtypes, clinicohistological factors and main clinical signs.	through study completion, an average of 9 years
Description of the cytokine and lymphocyte profile of each pathology.	Establish a molecular classification specific to each type of pathology: autoimmune diseases, systemic vasculitis and autoinflammatory diseases	through study completion, an average of 9 years

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France
• Investigators: Principal Investigator: David Saadoun, Professor, Assistance Publique - Hopitaux de Paris

Publications and helpful links

Helpful Links

• website for Immunology Department of la Pitié Salpétrière hospital (Département de Médecine Interne et Immunologie Clinique)

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Estimated): November 29, 2031
• Study Completion (Estimated): November 29, 2031

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 16, 2022
• First Posted (Actual): May 20, 2022

Study Record Updates

• Last Update Posted (Actual): July 3, 2025
• Last Update Submitted That Met QC Criteria: June 30, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Autoimmune Diseases; Vasculitis; Autoinflammatory Disease; disease activity biomarkers cytokine and lymphocyte profile
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Immune System Diseases; Autoimmune Diseases; Vasculitis
• Other Study ID Numbers: APHP220486

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No