Rheumatoid ArthritisImmun4CureNCT07515638
Immun4Cure Cohort of Autoimmune Diseases
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis
- What is being tested?
- Blood test and principal collection, Optional collection and Patient questionnaires
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 23 Jun 2026to 23 Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier - CIMA
Montpellier
Yves-Marie PERS, MD, secretariat.ihu@chu-montpellier.fr
Edouard TUAILLON, MD, secretariat.ihu@chu-montpellier.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers
- Being tested
- Blood test and principal collection, Optional collection, Patient questionnaires, Examination
- Keywords
- Autoimmune disease, multi-omic profiling, immunology
- Medical subject headings
- Arthritis, Rheumatoid, Lupus Erythematosus, Systemic, Scleroderma, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood test and principal collectionBiological
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 collectionBiological
The optional collection will include:
- stool sample (50 mL)
- urine sample (50 mL)
- saliva sample (2 mL)
Patient questionnairesOther
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
ExaminationOther
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1-Rheumatoid arthritis (RA) | Adults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria Receives: Biological: Blood test and principal collection; Biological: Optional collection; Other: Patient questionnaires; Other: Examination | |
| 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 Receives: Biological: Blood test and principal collection; Biological: Optional collection; Other: Patient questionnaires; Other: Examination | |
| Group 3-Systemic sclerosis (SSc) | Adults aged 18 years or older with a diagnosis of systemic sclerosis meeting the 2013 ACR/EULAR classification criteria Receives: Biological: Blood test and principal collection; Biological: Optional collection; Other: Patient questionnaires; Other: Examination | |
| 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 Receives: Biological: Blood test and principal collection; Biological: Optional collection; Other: Patient questionnaires; Other: Examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, disease flare (if applicable), and end of follow-up (Month 60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start23 Jun 2026
- Primary completion23 Jun 2031 (estimated)
- Study completion23 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yves-Marie PERS, Pr, Study director, University Hospital, MontpellierEdouard TUAILLON, Pr, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515638
- Sponsor's protocol ID
- RECHMPL24_0439
- Other IDs
- IdRCB
- Acronym
- Immun4Cure
- Status last verified
- Jun 2026
- First submitted
- 31 Mar 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Clinical and Biological Data in Patients With Autoimmune Diseases (Immun4Cure Cohort)
- ClinicalTrials.gov ID
- NCT07515638
- Acronym / sponsor ID
- Immun4Cure / RECHMPL24_0439
- Conditions
- Rheumatoid Arthritis, Systemic Lupus Erythematosus, Systemic Sclerosis, Healthy Adult Volunteers
- Keywords
- Autoimmune disease, multi-omic profiling, immunology
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 23 Jun 2026 (actual)
- Primary completion
- 23 Jun 2031 (estimated)
- Study completion
- 23 Jun 2034 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1-Rheumatoid arthritis (RA) | – | Biological: Blood test and principal collection, Biological: Optional collection, Other: Patient questionnaires, Other: ExaminationAdults aged 18 years or older with a diagnosis of rheumatoid arthritis meeting the 2010 ACR/EULAR classification criteria |
| Group 2-Systemic lupus erythematosus (SLE) | – | Biological: Blood test and principal collection, Biological: Optional collection, Other: Patient questionnaires, Other: ExaminationAdults aged 18 years or older with a diagnosis of systemic lupus erythematosus meeting the 2019 ACR/EULAR classification criteria |
| Group 3-Systemic sclerosis (SSc) | – | Biological: Blood test and principal collection, Biological: Optional collection, Other: Patient questionnaires, Other: ExaminationAdults 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] | – | Biological: Blood test and principal collection, Biological: Optional collection, Other: Patient questionnaires, Other: ExaminationAdults aged 18 years or older with no symptoms suggestive of autoimmune disease and no first-degree family history of confirmed autoimmune disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood test and principal collectionA 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 | Group 1-Rheumatoid arthritis (RA), Group 2-Systemic lupus erythematosus (SLE), Group 3-Systemic sclerosis (SSc), Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF] |
| Optional collectionThe optional collection will include: * stool sample (50 mL) * urine sample (50 mL) * saliva sample (2 mL) | Biological | Group 1-Rheumatoid arthritis (RA), Group 2-Systemic lupus erythematosus (SLE), Group 3-Systemic sclerosis (SSc), Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF] |
| Patient questionnairesFor 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 | Group 1-Rheumatoid arthritis (RA), Group 2-Systemic lupus erythematosus (SLE), Group 3-Systemic sclerosis (SSc), Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF] |
| ExaminationGroup 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 | Other | Group 1-Rheumatoid arthritis (RA), Group 2-Systemic lupus erythematosus (SLE), Group 3-Systemic sclerosis (SSc), Group 4-Healthy adult volunteers (controls) [2024-A0283...Immun4Cure | PDF] |
Primary outcome
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.
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yves-Marie PERS, Pr study director
University Hospital, Montpellier
Edouard TUAILLON, Pr study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Systemic Lupus Erythematosus, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charlotte KAAN (+334 67 33 48 53 ext. 33, depotac@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC-ROC discriminant performance of multi-omic biomarkers (time frame: Baseline to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.