Deployment o the Multidisciplinary Prospective Cohort Imminent

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04334031
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University Hospital, Lille
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David Launay, MD,PhD
Principal Investigator Affiliation University Hospital, Lille
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Chronic Inflammatory Disease, Angioedema, Severe Asthma, Lupus, Atopic Dermatitis, Psoriatic Arthritis, Multiple Sclerosis, Systemic Sclerosis, Behçet Disease
Arms & Interventions

Arms

Experimental: IMMINeNT cohort

Interventions

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.

Contact a Trial Team

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International Sites

Hop Claude Huriez Chu Lille, Lille, France

Status

Recruiting

Address

Hop Claude Huriez Chu Lille

Lille, , 59037

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