Immun4Cure Cohort of Autoimmune Diseases (Immun4Cure)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis; Systemic Lupus Erythematosus; Systemic Sclerosis; Healthy Adult Volunteers
• Intervention / Treatment: Biological: Blood test and principal collection; Biological: Optional collection; Other: Patient questionnaires; Other: Examination

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.

• Study Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Charlotte KAAN; Phone Number: 33 +334 67 33 48 53; Email: depotac@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1-Rheumatoid arthritis (RA); Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria	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, 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; 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 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; 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
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	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, 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; 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 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; 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
Group 3-Systemic sclerosis (SSc); Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria	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, 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; 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 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; 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
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	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, 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; 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 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, disease flare (if applicable), and end of follow-up (Month 60)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Yves-Marie PERS, Pr, Montpellier University Hospital; Study Director: Edouard TUAILLON, Pr, Montpellier University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): May 1, 2031
• Study Completion (Estimated): May 1, 2034

Study Registration Dates

• First Submitted: March 31, 2026
• First Submitted That Met QC Criteria: March 31, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Autoimmune disease; immunology; multi-omic profiling
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Immune System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic; Autoimmune Diseases; Scleroderma, Systemic; Arthritis, Rheumatoid; Investigative Techniques; Therapeutics; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Behavior Control; Immobilization; Restraint, Physical; Hematologic Tests
• Other Study ID Numbers: RECHMPL24_0439; IDRCB (Other Identifier: 2025-A01568-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No