Immun4Cure Cohort of Autoimmune Diseases

University Hospital Center (CHU)

Status: Enrolling

Conditions: Systemic Sclerosis; Healthy Adult Volunteers; Systemic Lupus Erythematosus; Rheumatoid Arthritis

Treatments: Other: Patient questionnaires; Other: Examination; Biological: Optional collection; Biological: Blood test and principal collection

Study type: Observational

Funder types: Other

Identifiers

NCT07515638

RECHMPL24_0439

IdRCB (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 4 patient groups

Group 1-Rheumatoid arthritis (RA)

Description:

Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria

Treatment:

Biological: Blood test and principal collection

Biological: Optional collection

Other: Examination

Other: Patient questionnaires

Group 2-Systemic lupus erythematosus (SLE)

Description:

Adults aged 18 years or older with a diagnosis of systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria

Treatment:

Biological: Blood test and principal collection

Biological: Optional collection

Other: Examination

Other: Patient questionnaires

Group 3-Systemic sclerosis (SSc)

Description:

Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria

Treatment:

Biological: Blood test and principal collection

Biological: Optional collection

Other: Examination

Other: Patient questionnaires

Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF]

Description:

Adults aged 18 years or older with no symptoms suggestive of autoimmune disease and no first-degree family history of confirmed autoimmune disease

Treatment:

Biological: Blood test and principal collection

Biological: Optional collection

Other: Examination

Other: Patient questionnaires