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Deployment o the Multidisciplinary Prospective Cohort Imminent (IMMINeNT)

Primary Purpose

Chronic Inflammatory Disease, Angioedema, Severe Asthma

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Biobanking with genetic analysis
SF-12 questionnaire
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Chronic Inflammatory Disease focused on measuring Immune Mediated Inflammatory Diseases (IMIDs), biomarker, cohort study, quality of life, disease severity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hop Claude Huriez Chu LilleRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

IMMINeNT cohort

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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).
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.
Change of Longhurst criteria for hereditary angioedema
for hereditary angioedema: Longhurst criteria
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%.
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)
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.
number of participant with severe infectious events

Secondary Outcome Measures

Full Information

First Posted
March 10, 2020
Last Updated
May 17, 2022
Sponsor
University Hospital, Lille
Collaborators
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)
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1. Study Identification

Unique Protocol Identification Number
NCT04334031
Brief Title
Deployment o the Multidisciplinary Prospective Cohort Imminent
Acronym
IMMINeNT
Official Title
Deployment o the Multidisciplinary Prospective Cohort Imminent
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
July 2031 (Anticipated)
Study Completion Date
July 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
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)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMMINeNT cohort
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
Biobanking with genetic analysis
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SF-12 questionnaire
Intervention Description
Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.
Primary Outcome Measure Information:
Title
Change of SLEDAI for lupus
Description
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.
Time Frame
once a year for 10 years
Title
Change of Medsger score
Description
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.
Time Frame
once a year for 10 years
Title
Change of EDSS for multiple sclerosis
Description
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).
Time Frame
once a year for 10 years
Title
Change of BASDAI for psoriatic arthristis
Description
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.
Time Frame
once a year for 10 years
Title
Change of Longhurst criteria for hereditary angioedema
Description
for hereditary angioedema: Longhurst criteria
Time Frame
once a year for 10 years
Title
Change of number of flares for atopic dermatitis
Description
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%.
Time Frame
once a year for 10 years
Title
Change of number of exacerbations for severe asthma
Description
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)
Time Frame
once a year for 10 years
Title
Change of 12-Item Short-Form Health Survey (SF-12) - quality of life scale
Description
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.
Time Frame
once a year for 10 years
Title
number of participant with severe infectious events
Time Frame
once a year for 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Launay, MD,PhD
Phone
03 20 44 42 95
Ext
+33
Email
david.launay@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Launay, MD,PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hop Claude Huriez Chu Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
Phone
0320445962

12. IPD Sharing Statement

Learn more about this trial

Deployment o the Multidisciplinary Prospective Cohort Imminent

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