Chronic Inflammatory DiseaseIMMINeNTNCT04334031
Deployment o the Multidisciplinary Prospective Cohort Imminent
A study testing Biobanking with genetic analysis and SF-12 questionnaire in people with Chronic Inflammatory Disease and Angioedema, run by University Hospital, Lille at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Inflammatory Disease, Angioedema, Severe Asthma
- What is being tested?
- Biobanking with genetic analysis and SF-12 questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jul 2020to 21 Jul 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hop Claude Huriez Chu Lille
Lille, 59037
0320445962
About this study
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
- Being tested
- Biobanking with genetic analysis, SF-12 questionnaire
- Keywords
- Immune Mediated Inflammatory Diseases (IMIDs), biomarker, cohort study, quality of life, disease severity
- Medical subject headings
- Angioedema, Asthma, Dermatitis, Atopic, Arthritis, Psoriatic, Multiple Sclerosis, Scleroderma, Systemic, Behcet Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biobanking with genetic analysisGenetic
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.
SF-12 questionnaireOther
Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| IMMINeNT cohort | Experimental | Not described Receives: Genetic: Biobanking with genetic analysis; Other: SF-12 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: once a year for 10 years
Change of Longhurst criteria for hereditary angioedema
for hereditary angioedema: Longhurst criteria
Measured: 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%.
Measured: 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)
Measured: 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.
Measured: once a year for 10 years
number of participant with severe infectious events
Measured: once a year for 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start20 Jul 2020
- Primary completion20 Jul 2031 (estimated)
- Study completion21 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- 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)
- Responsible party
- Sponsor
- Investigators
- David Launay, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334031
- Sponsor's protocol ID
- 2018_82
- Other IDs
- 2019-A01309-48
- Acronym
- IMMINeNT
- Status last verified
- Apr 2026
- First submitted
- 10 Mar 2020
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deployment o the Multidisciplinary Prospective Cohort Imminent
- ClinicalTrials.gov ID
- NCT04334031
- Acronym / sponsor ID
- IMMINeNT / 2018_82
- Conditions
- Chronic Inflammatory Disease, Angioedema, Severe Asthma, Lupus, Atopic Dermatitis, Psoriatic Arthritis
- Keywords
- Immune Mediated Inflammatory Diseases (IMIDs), biomarker, cohort study, quality of life, disease severity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,200 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- 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)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 20 Jul 2031 (estimated)
- Study completion
- 21 Jul 2031 (estimated)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMMINeNT cohort | Experimental | Genetic: Biobanking with genetic analysis, Other: SF-12 questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biobanking with genetic analysisPatients 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. | Genetic | IMMINeNT cohort |
| SF-12 questionnairePatients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire. | Other | IMMINeNT cohort |
Primary outcome
Change of SLEDAI for lupus
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
for hereditary angioedema: Longhurst criteria
Change of number of flares for atopic dermatitis
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
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
Time frame: once a year for 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Launay, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biobanking with genetic analysis and SF-12 questionnaire in people with Chronic Inflammatory Disease and Angioedema, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Launay, MD,PhD (03 20 44 42 95 ext. +33, david.launay@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of SLEDAI for lupus (time frame: once a year for 10 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.