Immun4Cure Cohort of Autoimmune Diseases
Immun4Cure
Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
2 other identifiers
observational
500
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2026
CompletedFirst Posted
Study publicly available on registry
April 7, 2026
CompletedStudy Start
First participant enrolled
June 23, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 23, 2034
June 30, 2026
June 1, 2026
5 years
March 31, 2026
June 26, 2026
Conditions
Keywords
Outcome Measures
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.
Baseline to 60 months
Secondary Outcomes (1)
Characterization of Pathophysiological Mechanisms Through Multi-Omic and Spatial Immune Profiling
Baseline, disease flare (if applicable), and end of follow-up (Month 60)
Study Arms (4)
Group 1-Rheumatoid arthritis (RA)
Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria
Group 2-Systemic lupus erythematosus (SLE)
Adults aged 18 years or older with a diagnosis of systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria
Group 3-Systemic sclerosis (SSc)
Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria
Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF]
Adults aged 18 years or older with no symptoms suggestive of autoimmune disease and no first-degree family history of confirmed autoimmune disease
Interventions
The optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL)
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
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
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
Eligibility Criteria
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
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- Patients who have refused or are unable to give informed consent
- Inability to follow the subject during the study period
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Montpellier - CIMA
Montpellier, France
Biospecimen
BLOOD COLLECTION: A total of 62.5 mL/participant. * 6 x 6 mL heparin tubes (immunophenotyping and plasma banking) * 1 x 6 mL EDTA tube (pan-genomic and epigenetic analyses at inclusion, then biobanking during follow-up) * 1 x 6 mL EDTA tube (proteomics) * 1 x 6 mL dry tube (storage and proteomics) * 1 x 6 mL heparinized tube (biobanking) * 1 x 2.5 mL Paxgene tube (transcriptomic analyses) Optional tissue samples: * Skin biopsy * Synovial microbiopsy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yves-Marie PERS, Pr
Montpellier University Hospital
- STUDY DIRECTOR
Edouard TUAILLON, Pr
Montpellier University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2026
First Posted
April 7, 2026
Study Start
June 23, 2026
Primary Completion (Estimated)
June 23, 2031
Study Completion (Estimated)
June 23, 2034
Last Updated
June 30, 2026
Record last verified: 2026-06