Immun4Cure Cohort of Autoimmune Diseases

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Adults ≥18 years

Disqualifiers

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

Trial population

The study population includes 450 adults with autoimmune diseases: 150 with rheumatoid arthritis, 150 with systemic lupus erythematosus, and 150 with systemic sclerosis, diagnosed according to international classification criteria and followed within participating clinical departments at Montpellier University Hospital. An additional 50 healthy adults without autoimmune symptoms or first-degree family history of autoimmune disease serve as controls

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Blood test and principal collection

    Biological/Vaccine

    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, CPK, fasting blood glucose, albumin, serum protein electrophoresis, total bilirubin, γGT, ASAT, ALAT, PAL, TSH, total cholesterol, LDL, HDL, triglycerides, B9, B12, HBV, HCV, HIV, CMV, EBV serology, antinuclear antibodies, DNA, ACPA, rheumatoid factor, C3, C4, proteinuria/creatininuria, urine strip test

  • Optional collection

    Biological/Vaccine

    The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)

  • Patient questionnaires

    Other intervention

    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 food diary For group 4: Self-questionnaires will assess factors such 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 food diary

  • Examination

    Other intervention

    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

Treatment groups

500 Participants
are divided into 4 treatment groups
Group A: Group 1-Rheumatoid arthritis (RA)4 interventions
Group B: Group 2-Systemic lupus erythematosus (SLE)4 interventions
Group C: Group 3-Systemic sclerosis (SSc)4 interventions
Group D: Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF]4 interventions

Trial outcomes

Primary outcomes

1

AUC-ROC discriminant performance of multi-omic biomarkers

Discriminatory power (AUC-ROC) of biological markers measured using a multi-omic approach (genomics, proteomics, transcriptomics, epitranscriptomics, immunology, metabolomics) common to adult patients with autoimmune disease (AID), compared to adults without AID.

Time frame
Baseline to 60 months

Secondary outcomes

1

Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling

Immune signatures from blood and tissue samples (including synovial, skin, and other available biopsies) will be analyzed to determine disease-specific patterns and their discriminative capacity across autoimmune diseases. Immune cells, particularly macrophages, will be isolated and profiled using single-cell-based spatial analyses. Samples will undergo multi-omic characterization, including proteomic, transcriptomic, epitranscriptomic, immunological, and metabolomic analyses, to identify disease-specific molecular and cellular signatures.

Time frame
Baseline, disease flare (if applicable), and end of follow-up (Month 60)

Other outcomes

Sponsors and contacts

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