Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures. This prospective cohort of patients with myositis will allow for identification of factors favouring the occurrence of myositis, whether they are constitutional (genetic) or acquired (environmental or drug). Different subgroups of myositis used for prognostication will be identified based on clinico-demographical variables, the nature of the organs involved beyond peripheral muscles (cardiac, diaphragm) and biomarkers abnormalities
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Suspicion of Myositis defined according to reference classifications: Dermatomyositis (DM), polymyositis (PM) defined as early as 1975 by Bohan and Peter, inclusion myositis (IM) according to the criteria of Griggs et al, 1995 and autoimmune necrotizing myopathy (ANM) by Hoogendijk et al, in 2004 and iatrogenic (e.g. drug-induced) myositis.
No opposition from patients to the use of their data
Signature of consents for the constitution of the biobank and the genetic analyses
Disqualifiers
Patients under AME
Patients under legal protection
Trial population
Major patients with myositis included during consultation visits or routine hospitalizations in the Internal Medicine Department, Reference Center for Neuromuscular Pathology, at the Pitié Salpêtrière Hospital
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Characterisation of the different myositis subgroups based on clinical, radiological, electrophysiological and histobiological evaluations
Characterisation of the different myositis subgroups based on clinical, radiological, electrophysiological and histobiological evaluations
Time frame
baseline: first 30 days after inclusionSecondary outcomes
1
Characterisation of the natural history of myositis subgroups :responses to treatments, prognosis factors, evolution
Characterisation of the natural history of myositis subgroups :responses to treatments, prognosis factors, evolution
Time frame
up to twenty years after inclusion2
Characterisation of an immune system signature, using peripheral blood mononuclear cells and muscular biopsies, DNA and RNA sequencing, and autoantibodies
Characterisation of an immune system signature, using peripheral blood mononuclear cells and muscular biopsies, DNA and RNA sequencing, and autoantibodies
Time frame
baseline: first 30 days after inclusion3
Risk factors for All-cause mortality depending on patient's and disease characteristics
Risk factors for All-cause mortality depending on patient's and disease characteristics including clinical, radiological electrophysiological, histo-biological and immunological as well as treatment received stratified by each subgroup of myositis
Time frame
up to twenty years after inclusion4
Change of the quality of life, using quality of life questionnaires, depending of patients and disease characteristics
Change of the quality of life, using quality of life questionnaires, depending of patients and disease characteristics (HAQ (Health Assessment Questionnaire)global health status scale (0-100))
Time frame
up to twenty years after inclusionSponsors and contacts
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Source ClinicalTrials.gov