About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Single group
Treatments tested in this trial
Biobanking with genetic analysis
GeneticPatients 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 questionnaire
Other interventionPatients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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University Hospital, Lille
Lead sponsor
FHU IMMINeNT
Collaborator
FHU PRECISE: Projet Fédératif Hospitalo-Universitaire PREcision health in Complex Immune-mediated inflammatory diseaSEs
Collaborator
Fond de dotation de la Société Française de Dermatologie (SFD)
Collaborator