Immun4Cure Cohort of Autoimmune Diseases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood test and principal collection, Optional collection, Patient questionnaires, Examination.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
Overview
This prospective cohort study aims to constitute a 500-participant database and biobank including 450 adults with systemic autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis) and 50 healthy controls.
Detailed description
The Immun4Cure Cohort is a monocentric prospective cohort conducted at Montpellier University Hospital. Autoimmune diseases (AIDs) are complex, heterogeneous conditions involving dysregulation of innate and adaptive immunity, chronic inflammation, and irreversible tissue damage. The three targeted diseases-rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and systemic sclerosis (SSc represent major public-health challenges due to their severity, treatment burden, and impact on quality of life.
The study integrates standardized longitudinal clinical follow-up over 5 years, deep phenotyping, multi-omic analyses (genomics, transcriptomics, proteomics, metabolomics, immunophenotyping), environmental exposure assessment, and biological sample collection (blood, serum, plasma, PBMCs, urine, stool, saliva, optional tissue biopsies).
Healthy subjects undergo baseline and 12-month evaluations to establish reference immune, metabolic, and environmental signatures. This cohort will serve as a foundational research platform for translational studies and ancillary projects on autoimmune diseases.
Interventions
- Biological Blood test and principal collection
A total of 62.5 mL of blood will be collected while fasting, using the following tubes: * one 2.5 mL PAXGene Blood RNA Tube * seven 6mL heparinised Tubes * two 6mL EDTA Tubes * one 6mL dry Tube As part of routine care for groups 1, 2, and 3, and specific to research for group 4: A biological research assessment (urine and blood): complete blood count, platelets, HbA1c, reticulocytes, schizocytes, haptoglobin, ionogram, troponin, NT-proBNP, calcium, CRP, creatinine, GFR, uric acid, ferritin, C - Biological Optional collection
The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL) - Other Patient questionnaires
For groups 1 to 3 : Self-questionnaires will assess factors such as medical history, comorbidity exposure to toxic substances, occupational exposures, psychological and clinical factors. occupation and household income, as well as lifestyle habits (tobacco and alcohol consumption, possible drug use, sexual activity). Anxiety and depression environmental factors throughout life (diet, physical activity, sleep, contraception, sun exposure, pollution, noise, proximity to green spaces, etc.), 3-day - Other Examination
Group 1-RA: Capillaroscopy and optionnal Synovial microbiopsy Group 2-SLE: Optical coherence tomography (OCT) and optionnal skin biopsy and optionnal capillaroscopy Group 3-SSc: Capillaroscopy and optionnal skin biopsy Group 4: Optical coherence tomography (OCT) and capillaroscopie. Optionnal skin biopsy and optionnal Synovial microbiopsy
Primary outcome measures
- AUC-ROC discriminant performance of multi-omic biomarkers [Time frame: Baseline to 60 months]
Secondary outcome measures (1)
- Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling [Time frame: Baseline, disease flare (if applicable), and end of follow-up (Month 60)]
Eligibility criteria
Inclusion Criteria Participants:
Group 1: RA
- Adults ≥18 years
- Patient followed as part of their MAI in one of the departments participating in the study at UHM
- Confirmed diagnosis according to international criteria :ACR/EULAR 2010
Group 2: LES
- Adults ≥18 years
- Patient followed as part of their MAI in one of the departments participating in the study at UHM
- Confirmed diagnosis according to international criteria :ACR/EULAR 2019
Group 3: SSc
- Adults ≥18 years
- Patient followed as part of their MAI in one of the departments participating in the study at UHM
- Confirmed diagnosis according to international criteria :ACR/EULAR 2013
Group 4: Healthy Controls
- Adults ≥18 years
- No symptoms of autoimmune disease
- No first-degree family history of autoimmune disease
Exclusion Criteria (all groupes):
- Patients who have refused or are unable to give informed consent
- Inability to follow the subject during the study period
- Participation in another interventional study that includes an exclusion period that is still ongoing
- Pregnant women
- Not affiliated with a social security scheme
- Patients without a national insurance number
- Persons under judicial protection, guardianship or trusteeship
- Persons deprived of their liberty
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- CHU de Montpellier - CIMA — Montpellier
Identifiers
NCT: NCT07515638 · RECHMPL24_0439 · IdRCB