Clinical trial NCT04334031: Deployment o the Multidisciplinary Prospective Cohort Imminent
Official title: Deployment o the Multidisciplinary Prospective Cohort Imminent
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: FHU IMMINeNT
name: FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs
name: Fond de dotation de la Société Française de Dermatologie (SFD)
First posted: 2020-04-03
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change of SLEDAI for lupus
timeFrame: once a year for 10 years
measure: Change of Medsger score
timeFrame: once a year for 10 years
measure: Change of EDSS for multiple sclerosis
timeFrame: once a year for 10 years
measure: Change of BASDAI for psoriatic arthristis
timeFrame: once a year for 10 years
measure: Change of Longhurst criteria for hereditary angioedema
timeFrame: once a year for 10 years
measure: Change of number of flares for atopic dermatitis
timeFrame: once a year for 10 years
measure: Change of number of exacerbations for severe asthma
timeFrame: once a year for 10 years
measure: Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale
timeFrame: once a year for 10 years
measure: number of participant with severe infectious events
timeFrame: once a year for 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hop Claude Huriez Chu Lille
Study officials:
affiliation: University Hospital, Lille
name: David Launay, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: