Autoimmune DiseasesBIOMAINCT05383339
Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
An observational study of Autoimmune Diseases and Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autoimmune Diseases, Vasculitis, Autoinflammatory Disease
- What is being tested?
- Blood collection
- How many people
- 2,250 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2022to 29 Nov 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with autoimmune diseases, systemic vasculitis and/or autoinflammatory disease
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Département de Médecine Interne et Immunologie Clinique (DMIIC), Hôpital Pitié-Salpêtrière
Paris, France, 75013
David Saadoun, Professor, +33142161051, david.saadoun@aphp.fr
Nassima Mansour, +33184828101, nassima.mansour@aphp.fr
About this study
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.
Read the 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.
- Conditions
- Autoimmune Diseases, Vasculitis, Autoinflammatory Disease
- Being tested
- Blood collection
- Keywords
- Autoimmune Diseases, Vasculitis, Autoinflammatory Disease, disease activity biomarkers cytokine and lymphocyte profile
- Medical subject headings
- Autoimmune Diseases, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionOther
- 56mL blood collected additionally to routine care
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with autoimmune diseases, vasculitis and autoinflammatory diseases Receives: Other: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 9 years
Secondary outcomes (5)
Characterization of new cytokines involved in these pathologies
Characterization of new cytokines involved in autoimmune diseases, systemic vasculitis and autoinflammatory diseases using ELISA analysis..
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: through study completion, an average of 9 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2022
- Study start29 Nov 2022
- Primary completion29 Nov 2031 (estimated)
- Study completion29 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Saadoun, Professor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05383339
- Sponsor's protocol ID
- APHP220486
- Acronym
- BIOMAI
- Status last verified
- Jun 2025
- First submitted
- 9 May 2022
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Autoimmune Diseases, Vasculitis and Auto Inflammatory Diseases
- ClinicalTrials.gov ID
- NCT05383339
- Acronym / sponsor ID
- BIOMAI / APHP220486
- Conditions
- Autoimmune Diseases, Vasculitis, Autoinflammatory Disease
- Keywords
- Autoimmune Diseases, Vasculitis, Autoinflammatory Disease, disease activity biomarkers cytokine and lymphocyte profile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,250 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 29 Nov 2031 (estimated)
- Study completion
- 29 Nov 2031 (estimated)
- First posted
- 20 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Blood collectionPatients with autoimmune diseases, vasculitis and autoinflammatory diseases |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with autoimmune diseases, systemic vasculitis and/or autoinflammatory disease
Key inclusion criteria (11 listed)
- 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:
- Patients affiliated to French social security
Key exclusion criteria (5 listed)
- Vulnerable populations:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection- 56mL blood collected additionally to routine care | Other | Patients |
Primary outcome
Correlation between cytokine and lymphocyte profile and disease activity
Time frame: 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.
5 secondary outcomes
Characterization of new cytokines involved in these pathologies
Time frame: through study completion, an average of 9 years
Characterization of new lymphocytes types involved in these pathologies
Time frame: 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.)
Time frame: through study completion, an average of 9 years
Correlation between the cytokine and lymphocyte profile, and the clinical presentation of each pathology
Time frame: through study completion, an average of 9 years
Description of the cytokine and lymphocyte profile of each pathology.
Time frame: through study completion, an average of 9 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- website for Immunology Department of la Pitié Salpétrière hospital (Département de Médecine Interne et Immunologie Clinique)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Saadoun, Professor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Diseases and Vasculitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Saadoun, Professor (+33142161051, david.saadoun@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between cytokine and lymphocyte profile and disease activity (time frame: through study completion, an average of 9 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.