Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases

NCT ID: NCT05383339

Last Updated: 2025-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2031-11-29

Brief Summary

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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

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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.

Conditions

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Autoimmune Diseases Vasculitis Autoinflammatory Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with autoimmune diseases, vasculitis and autoinflammatory diseases

Blood collection

Intervention Type OTHER

\- 56mL blood collected additionally to routine care

Interventions

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Blood collection

\- 56mL blood collected additionally to routine care

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Saadoun, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Département de Médecine Interne et Immunologie Clinique (DMIIC), Hôpital Pitié-Salpêtrière

Paris, France, France

Site Status RECRUITING

Countries

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France

Central Contacts

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David Saadoun, Professor

Role: CONTACT

+33142161051

Nassima Mansour

Role: CONTACT

+33184828101

Facility Contacts

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David Saadoun, Professor

Role: primary

+33142161051

Nassima Mansour

Role: backup

+33184828101

Related Links

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http://www.maladiesautoimmunes.com/

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

Other Identifiers

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APHP220486

Identifier Type: -

Identifier Source: org_study_id

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