Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases

NCT05383339 | Recruiting

• 1 other identifier: APHP220486
• Study Type: observational
• Target: 2,250
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Diseases; Vasculitis; Autoinflammatory Disease

Keywords

Autoimmune Diseases; Vasculitis; Autoinflammatory Disease; disease activity biomarkers cytokine and lymphocyte profile

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Characterization of new cytokines involved in these pathologies

  through study completion, an average of 9 years

• Characterization of new lymphocytes types involved in these pathologies

  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.)

  through study completion, an average of 9 years

• Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology

  through study completion, an average of 9 years

• Description of the cytokine and lymphocyte profile of each pathology.

  through study completion, an average of 9 years

Study Arms (1)

Patients

Patients with autoimmune diseases, vasculitis and autoinflammatory diseases

Other: Blood collection

Interventions

Blood collection OTHER

\- 56mL blood collected additionally to routine care

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

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

Paris, France, 75013, France

RECRUITING

Related Links

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

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

Autoimmune Diseases; Vasculitis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Immune System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• David Saadoun, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Saadoun, Professor

CONTACT

+33142161051; david.saadoun@aphp.fr

Nassima Mansour

CONTACT

+33184828101; nassima.mansour@aphp.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2022
• First Posted: May 20, 2022
• Study Start: November 29, 2022
• Primary Completion (Estimated): November 29, 2031
• Study Completion (Estimated): November 29, 2031
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

FR (1)