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NCT Number: NCT07515638

Immun4Cure Cohort of Autoimmune Diseases

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Healthy Adult Volunteers Immune System Diseases Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Rheumatic Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Systemic Lupus Erythematosus Systemic Sclerosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Montpellier - CIMA

Montpellier, France

Location status: Recruiting

Location contact

Edouard TUAILLON, MD

CONTACT

[email protected]

Yves-Marie PERS, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test and principal collection

Biological

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

The optional collection will include:

  • stool sample (50 mL)
  • urine sample (50 mL)
  • saliva sample (2 mL)

Patient questionnaires

Other

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

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 outcomes

  1. AUC-ROC discriminant performance of multi-omic biomarkers

    Time frame: Baseline to 60 months

    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.

Secondary outcomes

  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)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte KAAN

CONTACT

[email protected]

+334 67 33 48 53 ext. 33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)

Acronym: Immun4Cure

Important dates

Study start
2026
Primary completion
2031
Study completion
2034
First posted
Apr 7, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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