Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank

NCT05454527 | Recruiting

• 1 other identifier: APHP220491
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 2

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

Conditions

Inflammatory Myositis; Idiopathic Inflammatory Myositis; Drug-induced Inflammatory Myositis

Outcome Measures

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

  baseline: first 30 days after inclusion

Secondary Outcomes (38)

• Characterisation of the natural history of myositis subgroups :responses to treatments, prognosis factors, evolution

  up to twenty years after inclusion

• Characterisation of an immune system signature, using peripheral blood mononuclear cells and muscular biopsies, DNA and RNA sequencing, and autoantibodies

  baseline: first 30 days after inclusion

• Risk factors for All-cause mortality depending on patient's and disease characteristics

  up to twenty years after inclusion

• Change of the quality of life, using quality of life questionnaires, depending of patients and disease characteristics

  up to twenty years after inclusion

• Change of activity impairment using an evaluation of daily life activity by both patient and physician using a Visual Analogue Scale depending of patients and disease characteristics

  up to twenty years after inclusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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

You may qualify if:

• Age ≥ 18 years
• No opposition from patients to the use of their data
• Signature of consents for the constitution of the biobank and the genetic analyses

You may not qualify if:

• Patients under AME
• Patients under legal protection

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (2)

Département de médecine interne et immunolgie clinique, Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Département de pharmacologie clinique, Hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Related Publications (2)

• Power JR, Dolladille C, Ozbay B, Procureur A, Ederhy S, Palaskas NL, Lehmann LH, Cautela J, Courand PY, Hayek SS, Zhu H, Zaha VG, Cheng RK, Alexandre J, Roubille F, Baldassarre LA, Chen YC, Baik AH, Laufer-Perl M, Tamura Y, Asnani A, Francis S, Gaughan EM, Rainer PP, Bailly G, Flint D, Arangalage D, Cariou E, Florido R, Narezkina A, Liu Y, Sandhu S, Leong D, Issa N, Piriou N, Heinzerling L, Peretto G, Crusz SM, Akhter N, Levenson JE, Turker I, Eslami A, Fenioux C, Moliner P, Obeid M, Chan WT, Ewer SM, Kassaian SE, Johnson DB, Nohria A, Ben Zadok OI, Moslehi JJ, Salem JE; International ICI-Myocarditis Registry. Immune checkpoint inhibitor-associated myocarditis: a novel risk score. Eur Heart J. 2025 Jun 18:ehaf315. doi: 10.1093/eurheartj/ehaf315. Online ahead of print.

  PMID: 40569849 DERIVED

• Power JR, Dolladille C, Ozbay B, Procureur AM, Ederhy S, Palaskas NL, Lehmann LH, Cautela J, Courand PY, Hayek SS, Zhu H, Zaha VG, Cheng RK, Alexandre J, Roubille F, Baldassarre LA, Chen YC, Baik AH, Laufer-Perl M, Tamura Y, Asnani A, Francis S, Gaughan EM, Rainer PP, Bailly G, Flint D, Arangalage D, Cariou E, Florido R, Narezkina A, Liu Y, Sandhu S, Leong D, Issa N, Piriou N, Heinzerling L, Peretto G, Crusz SM, Akhter N, Levenson JE, Turker I, Eslami A, Fenioux C, Moliner P, Obeid M, Chan WT, Ewer SM, Kassaian SE; International ICI-Myocarditis Registry; Johnson DB, Nohria A, Zadok OIB, Moslehi JJ, Salem JE. Predictors and Risk Score for Immune Checkpoint-Inhibitor-Associated Myocarditis Severity. medRxiv [Preprint]. 2024 Jun 3:2024.06.02.24308336. doi: 10.1101/2024.06.02.24308336.

  PMID: 38883792 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

biopsy residual samples

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Olivier Benveniste, PU PH

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

• Yves Allenbach

  Groupe Hospitalier Pitie-Salpetriere

  STUDY DIRECTOR

Central Study Contacts

Joe-Elie SALEM, MD PhD

CONTACT

142178531; joe-elie.salem@aphp.fr

Olivier Benveniste, PU PH

CONTACT

olivier.benveniste@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2022
• First Posted: July 12, 2022
• Study Start: October 26, 2022
• Primary Completion (Estimated): October 26, 2057
• Study Completion (Estimated): October 26, 2057
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)