Deployment o the Multidisciplinary Prospective Cohort Imminent (NCT04334031) | Clinical Trial Compass
RecruitingNot Applicable
Deployment o the Multidisciplinary Prospective Cohort Imminent
France2,200 participantsStarted 2020-07-20
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is tracking disease activity scores specific to my condition — like the SLEDAI for lupus or the EDSS for multiple sclerosis — over time, so would joining this cohort actually change the treatment I receive, or would I mainly be contributing data while continuing my existing care plan?
2Since this is listed as a 'not applicable' phase and appears to be an observational cohort study rather than a drug trial, what exactly would be expected of me in terms of visits, tests, or data collection, and how might that fit into my current schedule of appointments?
3The study is measuring severe infectious events as one of its primary outcomes — does that mean there's a known or suspected infection risk associated with the treatments being tracked in this cohort, and is that something I should be weighing against my current treatment options?
4Given that this cohort covers a wide range of conditions like severe asthma, angioedema, psoriatic arthritis, and systemic sclerosis, would the data collected about my specific condition be meaningful enough to help guide my own care, or is the benefit mainly to future patients?
5Before considering joining this cohort, should I first discuss whether my current treatment plan is optimized for my condition, and would participating in this study in any way delay or complicate access to newer therapies if my disease activity worsens?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of SLEDAI for lupus
Timeframe: once a year for 10 years
2
Change of Medsger score
Timeframe: once a year for 10 years
3
Change of EDSS for multiple sclerosis
Timeframe: once a year for 10 years
4
Change of BASDAI for psoriatic arthristis
Timeframe: once a year for 10 years
5
Change of Longhurst criteria for hereditary angioedema
Timeframe: once a year for 10 years
6
Change of number of flares for atopic dermatitis
Timeframe: once a year for 10 years
7
Change of number of exacerbations for severe asthma