- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02466217
Phenomics in Autoimmune and Inflammatory Diseases (TRANSIMMUNOM)
Clinical and Multi-omics Cross-phenotyping of Patients With Autoimmune and Auto-inflammatory Diseases
Study Overview
Status
Conditions
- Rheumatoid Arthritis
- Uveitis
- Vasculitis
- Type 1 Diabetes
- Crohn's Disease
- Myositis
- Healthy Volunteer
- Ankylosing Spondylitis
- FMF
- Systemic Lupus Erythematosus/Antiphospholipid Syndrome
- Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome
- Ulcerative Rectocolitis
- Unclassified IAD Knee and/or Hip Arthritis, Muscular Dystrophy
Intervention / Treatment
Detailed Description
The family of inflammatory/autoimmune systemic diseases (IAD) represents a large group of human diseases. For most if not all of these IAD, the pathophysiological processes or exact causes remain poorly understood. Progresses in molecular understanding of these IAD have led to realize that these are not two distinct categories of diseases. Rather they form a continuum from pure inflammatory diseases to pure autoimmune diseases, encompassing a large panel of inflammatory diseases with some autoimmune components, and vice versa.
Using systems biology, the investigator aims to improve the understanding of these diseases, to identify novel genes/pathways involved, specific or across the diseases, and to discover biomarkers and potential therapeutic targets.
The investigator will study adult patients with at least one of the following IAD: Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, Familial Mediterranean Fever (FMF), Cryopyrin-Associated Periodic Syndromes (CAPS) /Tumor Necrosis Factor-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes. This panel will be completed by controls groups: healthy volunteers, and patients with arthritis (knee and/or hip) or muscular dystrophy.
The biological investigations will notably comprise: immunomics (comprehensive evaluation of peripheral blood cell subsets and serum immunoproteomics, including autoantibodies); transcriptomics; Human Leukocyte Antigen (HLA)-phenotyping; genomics; T-Cell Receptor (TCR) sequencing and microbiota studies.
After signing the informed consent, the subject attends only one visit (Day 0) during which all biological samples will be taken and all clinical information collected.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Contact
- Name: David KLATZMANN, MD, PhD
- Phone Number: 0033 1 42 17 74 61
- Email: david.klatzmann@upmc.fr
Study Contact Backup
- Name: Roberta LORENZON, MD
- Phone Number: 33 1 42 17 85 33
- Email: roberta.lorenzon@upmc.fr
Study Locations
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-
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Paris, France, 75012
- Rhumatologie - Hôpital Saint-Antoine
-
Paris, France, 75013
- CIC Paris-Est, Hôpital PITIE SALPETRIERE
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Presenting either:
- one IAD from our list (Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/Tumor Necrosis Factor (TNF)-receptor Associated Periodic Syndrome, Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes)
- or an unclassified IAD : a knee and/or hip arthritis or a muscular dystrophy
- or healthy subject
- Good veins
- Affiliation to a social security system
- Informed consent form, signed by the participant and the investigator, prior all needed examination
Exclusion Criteria:
For IADs patients
- Unauthorized treatment (anticancer chemotherapy)
For Healthy volunteers
- Contra-indications for donating blood except from age
- Known history of IAD (eg: Psoriasis)
Common exclusion criteria:
- Pregnant woman
- Still under the exclusion period from another biomedical study
- Psychiatric or addiction pathology who could interfere with the ability to fulfill the protocol needs or to provide an informed consent
- Patient under a legal protection
- Chronic lifelong viral infection unrelated to the pathology
- Mild infection within the last 3 months
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1: AID groups
Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes (CAPS)/TNF-receptor Associated Periodic Syndrome (TRAPS), Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative colitis, Type 1 Diabetes
|
Clinical and Biological investigations
|
2: Control groups
knee arthritis, hip arthritis, muscular dystrophy, healthy subject
|
Clinical and Biological investigations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total peripheral blood gene expression between patients, expressed as fluorescence intensity
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
Tregs and Tconvs T cell receptor repertoire, expressed as the % of unique TCR sequences
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
HLA type and SNPs expressed as the occurrence events across patients
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
Microbiote species identification expressed as the % of species per family and genus
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
Cytokines and chemokines expressed as fluorescence intensity
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
Immune cells phenotyping expressed as the each cell type % within total PBMCs
Time Frame: at day 0, no follow-up
|
Identification of novel molecular and cellular pathways involved either in specific diseases or across the IAD continuum through a multiparametric approach
|
at day 0, no follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in gene expression intensity between patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Changes in Tregs and Tconvs TCR sequence frequencies between patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Characterization of HLA and SNP profiles in patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Changes in Microbiote composition between patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Changes in cytokines and chemokines expression levels between patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Changes in immune cells frequencies between patients and healthy controls - for each Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Identification of specific and common gene expression levels between patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Identification of specific and common Tregs and Tconvs TCR sequence frequencies between patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Characterization of specific and common HLA and SNP profiles in patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Identification of specific and common microbiote composition between patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Identification of specific and common cytokines and chemokines expression levels between patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Characterization specific and common variations in immune cells frequencies between patients - between Disease cohorts
Time Frame: at day 0, no follow-up
|
Identification of new biomarkers and potential therapeutic by multiscale analysis
|
at day 0, no follow-up
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: David KLATZMANN, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Nervous System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Hypersensitivity, Immediate
- Eye Diseases
- Disease Attributes
- Disease
- Gastrointestinal Diseases
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Muscular Diseases
- Neuromuscular Diseases
- Colonic Diseases
- Intestinal Diseases
- Rectal Diseases
- Uveal Diseases
- Hereditary Autoinflammatory Diseases
- Skin Diseases, Genetic
- Skin Diseases, Vascular
- Hypersensitivity
- Muscular Disorders, Atrophic
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Spondylarthritis
- Bone Diseases, Infectious
- Ankylosis
- Urticaria
- Colitis
- Chronic Disease
- Sigmoid Diseases
- Proctitis
- Chronic Inducible Urticaria
- Chronic Urticaria
- Axial Spondyloarthritis
- Syndrome
- Arthritis
- Lupus Erythematosus, Systemic
- Muscular Dystrophies
- Crohn Disease
- Myositis
- Vasculitis
- Antiphospholipid Syndrome
- Uveitis
- Spondylitis
- Spondylitis, Ankylosing
- Cryopyrin-Associated Periodic Syndromes
- Proctocolitis
Other Study ID Numbers
- P141006
- 2015-A00558-41 (Other Identifier: EUDRACT)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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