Deployment o the Multidisciplinary Prospective Cohort Imminent

NCT04334031 | Recruiting

• 2 other identifiers: 2018_822019-A01309-48
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

Brief Summary

Immune-mediated inflammatory diseases (IMIDs) most often affect young patients and have high impact on morbidity and mortality with a significant alteration in the quality of life of patients with professional, social and emotional repercussions. Beyond this burden, IMIDs share many common pathophysiological mechanisms and treatments, known as "targeted therapies". Despite progress in this field, much remains to be done in clinical, therapeutic and fundamental research to address the efficacy, resistance and side-effects of treatment. These similarities between IMIDs have led the FHU IMMINeNT to propose the creation of a prospective, multidisciplinary clinical-biological database (IMMINeNT cohort), associated to a biobank, of patients with IMIDs. The main objectives of this database will be to identify new prognostic and therapeutic biomarkers in order to develop new therapeutic targets and biomarkers, to identify prognostic factors and determinants related to the activity, severity and quality of life of patients with IMIDs as well as to the response and tolerance to treatment.

Conditions

Chronic Inflammatory Disease; Angioedema; Severe Asthma; Lupus; Atopic Dermatitis; Psoriatic Arthritis; Multiple Sclerosis; Systemic Sclerosis; Behçet Disease

Keywords

Immune Mediated Inflammatory Diseases (IMIDs); biomarker; cohort study; quality of life; disease severity

Outcome Measures

Primary Outcomes (9)

• Change of SLEDAI for lupus

  for lupus:Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) The SLEDAI score calculator consists of a list of 24 items, 16 clinical and 8 laboratory results.The total score falls between 0 and 105, with higher scores representing increased disease activity.

  once a year for 10 years

• Change of Medsger score

  Medsger Score estimates disease involvement of each organ (heart, vessels, skin, brain, kidney, gut, muscle, joint and loss of weight,) ranging from 0 to 4 (0: normal, 1: mild, 2: moderate, 3: severe, 4: terminal). The score ranges from 0 to 36 points.A higher score means a worse outcome.

  once a year for 10 years

• Change of EDSS for multiple sclerosis

  for multiple sclerosis:Expanded Disability Status Scale (EDSS) The EDSS quantifies disability in eight Functional Systems (FS) by assigning a Functional System Score (FSS) in each of these functional systems EDSS steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.EDSS score is a specific multiple sclerosis scale, from 0 (normal neurological status) to 10 (death kinked to sclerosis).

  once a year for 10 years

• Change of BASDAI for psoriatic arthristis

  For psoriatic arthritis:Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) he BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS: Fatigue/Spinal pain/Arthralgia (joint pain) or swelling/Enthesitis, or inflammation of tendons and ligaments (areas of localized tenderness where connective tissues insert into bone)/Morning stiffness duration/Morning stiffness severity.

  once a year for 10 years

• Change of Longhurst criteria for hereditary angioedema

  for hereditary angioedema: Longhurst criteria

  once a year for 10 years

• Change of number of flares for atopic dermatitis

  There is no validated score for atopic dermatitis and severe asthma.For atopic dermatitis, disease activity will be assessed by the number of flares per month with any affected body surface area (ACS) and the number of flares with body surface area \>20%.

  once a year for 10 years

• Change of number of exacerbations for severe asthma

  For severe asthma, disease activity will be assessed by the number of exacerbations per month, where an exacerbation is defined as a loss of control resulting in an increase in beta2mimetic intake (\>2 times daily compared to usual) and/or asthma-related limitation of daily activity and/or peak-flow change \>30% from baseline on at least 2 consecutive days)

  once a year for 10 years

• Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale

  Health-related Quality of Life variable measured using the Short Form Health Survey (SF12): 12-item self-report that assesses physical and mental health related quality of life. Results are expressed in terms of two meta-scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). The PCS and MCS scores have a range of 0 to 100 and were designed to have a mean score of 50. Higher scores indicate better physical functioning.

  once a year for 10 years

• number of participant with severe infectious events

  once a year for 10 years

Study Arms (1)

IMMINeNT cohort

EXPERIMENTAL

Genetic: Biobanking with genetic analysis; Other: SF-12 questionnaire

Interventions

Biobanking with genetic analysis GENETIC

Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.

IMMINeNT cohort

SF-12 questionnaire OTHER

Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.

IMMINeNT cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient followed for their IMID in one of the departments of the Lille University Hospital participating in the study (dermatology, internal medicine, neurology, pneumology and rheumatology)
• Social insured
• Have the capacity to understand the study requirements, provide written informed consent, and comply with the study data collection procedures.

You may not qualify if:

• Administrative reasons: inability to receive informed information, inability to participate in the entire study, lack of coverage by the social security system.
• Pregnant or breastfeeding woman
• Persons deprived of liberty
• Protected minors or adults
• Persons who have refused or are incapable of giving informed consent
• Persons in Emergency Situations

Sponsors & Collaborators

• University Hospital, Lille: lead
• FHU IMMINeNT: collaborator
• Fond de dotation de la Société Française de Dermatologie (SFD): collaborator
• FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs: collaborator

Study Sites (1)

Hop Claude Huriez Chu Lille

Lille, 59037, France

RECRUITING

MeSH Terms

Conditions

Angioedema; Asthma; Dermatitis, Atopic; Arthritis, Psoriatic; Multiple Sclerosis; Scleroderma, Systemic; Behcet Syndrome

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases, Eczematous; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Connective Tissue Diseases; Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveitis; Uveal Diseases; Eye Diseases; Vasculitis; Hereditary Autoinflammatory Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• David Launay, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Launay, MD,PhD

CONTACT

03 20 44 42 95; david.launay@chru-lille.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: April 3, 2020
• Study Start: July 20, 2020
• Primary Completion (Estimated): July 20, 2031
• Study Completion (Estimated): July 21, 2031
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)