Follow-up of patients with inflammatory myopathies and a biobank
Follow-up of a Cohort of Patients With Inflammatory Myopathies Associated With a Biobank: MASC 2 Project (Myositis, Muscles, DNA/RNA Serum Cells)
This study is trying to gather information from people with inflammatory myopathies to better understand the disease and find new treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Paris and 1 other locations) |
| Trial ID | NCT05454527 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a cohort of patients with inflammatory myopathies to better understand the disease's underlying mechanisms and identify potential treatments. It will involve collecting a wide range of clinical, radiological, and biological data, including muscle biopsies and blood samples, to establish a biobank. Patients will undergo regular follow-up visits to assess muscle strength, function, and other relevant health metrics. The goal is to delineate factors contributing to myositis and improve prognostication based on various clinical variables.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a suspicion of myositis, including various subtypes such as dermatomyositis and polymyositis.
Not a fit: Patients under legal protection or those who oppose the use of their data will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment options for patients with inflammatory myopathies.
How similar studies have performed: While myositis is a rare condition, similar cohort studies have shown promise in understanding autoimmune diseases, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris and 1 other locations
- Département de médecine interne et immunolgie clinique, Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
- Département de pharmacologie clinique, Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Joe-Elie SALEM, MD PhD
- Email: joe-elie.salem@aphp.fr
- Phone: 142178531
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.