TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)
NCT07355257
Inflammatory Myopathy, Muscular Diseases
View Trial DetailsNCT Number: NCT05982041
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 20 years
On the basis of the late gadolinium enhancement (LGE) positive by CMR
Time frame: 20 years
On the basis of extra-cellular volume (ECV) > 30% by CMR
Time frame: 20 years
This will depend on the specific biomarker/cytokine being measured
Time frame: 20 years
Specific identified genetic variants will be identified as part of large scale genetic studies
Time frame: 20 years
Contact information is provided by the study sponsor or research team.
The First Affiliated Hospital with Nanjing Medical University
Other
A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment in Adult Idiopathic Inflammatory Myopathy With Cardiac Injury
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