NCT05454527 Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank
| NCT ID | NCT05454527 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Inflammatory Myositis |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2022-10-26 |
| Primary Completion | 2057-10-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2022-10-26 with a primary completion date of 2057-10-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 Exclusion Criteria: * Patients under AME * Patients under legal protection
Contact & Investigator
Olivier Benveniste, PU PH
STUDY DIRECTOR
Groupe Hospitalier Pitie-Salpetriere
Frequently Asked Questions
Who can join the NCT05454527 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Inflammatory Myositis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05454527 currently recruiting?
Yes, NCT05454527 is actively recruiting participants. Contact the research team at joe-elie.salem@aphp.fr for enrollment information.
Where is the NCT05454527 trial being conducted?
This trial is being conducted at Paris, France, Paris, France.
Who is sponsoring the NCT05454527 clinical trial?
NCT05454527 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Olivier Benveniste, PU PH at Groupe Hospitalier Pitie-Salpetriere. The trial plans to enroll 4,000 participants.