Phenomics in Autoimmune and Inflammatory Diseases

  • STATUS
    Recruiting
  • End date
    Jul 20, 2025
  • participants needed
    1300
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 20 December 2021
diabetes
systemic disease
tumor necrosis factor
ulcerative colitis
myositis
autoimmune disease
vasculitis
arthritis
muscular dystrophy
crohn's disease
tumor necrosis factor alpha
uveitis
tumour necrosis
colitis
lupus
autoimmune diseases
ulceration
ankylosing spondylitis
Accepts healthy volunteers

Summary

The family of inflammatory/autoimmune systemic diseases (IAD) 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. Cross phenotyping of patients with IAD should be heuristic and help revise the nosography and the understanding of these diseases.

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.

Details
Condition Healthy Volunteer, Rheumatoid Arthritis, Ankylosing Spondylitis, Systemic Lupus Erythematosus/Antiphospholipid Syndrome, FMF, Cryopyrin-Associated Periodic Syndromes /TNF-receptor Associated Periodic Syndrome, Vasculitis, Uveitis, Myositis, Crohn's Disease, Ulcerative Rectocolitis, Type 1 Diabetes, Unclassified IAD Knee and/or Hip Arthritis, Muscular Dystrophy
Treatment 1: AID groups, 2: Control groups
Clinical Study IdentifierNCT02466217
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on20 December 2021

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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