Deployment o the Multidisciplinary Prospective Cohort Imminent

Multiple Sclerosis Clinical Trial

— IMMINeNT  

Official title:

Deployment o the Multidisciplinary Prospective Cohort Imminent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04334031
• Other study ID #: 2018_82
• Secondary ID: 2019-A01309-48
• Status: Recruiting
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: July 2031

Study information

• Verified date: May 2022
• Source: University Hospital, Lille
• Contact: David Launay, MD,PhD
• Phone: 03 20 44 42 95
• Email: david.launay[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2200
• Est. completion date: July 2031
• Est. primary completion date: July 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Arthritis, Psoriatic
• Atopic Dermatitis
• Behçet Disease
• Behcet Syndrome
• Chronic Inflammatory Disease
• Dermatitis
• Lupus
• Multiple Sclerosis
• Psoriatic Arthritis
• Scleroderma, Systemic
• Sclerosis
• Severe Asthma
• Systemic Sclerosis

Intervention

Genetic:
• Biobanking with genetic analysis
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.

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

Locations

Country	Name	City	State
France	Hop Claude Huriez Chu Lille	Lille

Sponsors (4)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change of Longhurst criteria for hereditary angioedema	for hereditary angioedema: Longhurst criteria	once a year for 10 years
Primary	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
Primary	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
Primary	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
Primary	number of participant with severe infectious events		once a year for 10 years