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Clinical Trial Summary

Adult patients with suspected or confirmed idiopathic inflammatory myopathy (IIM) will be recruited. Patients will be approached, consented, have baseline demographics, diagnostics and disease activity measures recorded, and blood taken. The collection of data and biological material will mirror usual clinical practice as far as possible. Subjects will ideally attend further visits at 3, 6 and 12 months to have bloods taken, outcome measures recorded and questionnaires completed.In addition, blood, muscle biopsies and imaging undertaken as part of usual care will also be collected for research purposes to measure a number of biomarkers for the assessment of diagnostic accuracy and clinical utility evaluation. As per usual practice, a muscle biopsy will be performed at baseline, and a further biopsy offered at 6 months to assess treatment response. A magnetic resonance (MR) muscle protocol will also be performed as per usual clinical practice, and a gadolinium-enhanced MR heart scan offered. Both these scans will be repeated at 6-12 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05982041
Study type Observational [Patient Registry]
Source The First Affiliated Hospital with Nanjing Medical University
Contact Qiang Wang, MD PHD
Phone 862568307588
Email jerrytortoise@163.com
Status Not yet recruiting
Phase
Start date January 1, 2024
Completion date January 1, 2043

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