MYOPROSP - a Prospective Cohort Study in Myositis

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 months. An existing electronic database entry system will be used for data entry and capture on an anonymised basis.

The study will thus be based around diagnostic evaluations and outcome measures to improve quality of care in IIM.

Conditions

• Myositis
• Idiopathic Inflammatory Myopathy

Sponsors & Collaborators

• University of Bath

  collaborator OTHER

• University College, London

  collaborator OTHER

• Royal Victoria Infirmary

  collaborator OTHER

• King's College Hospital NHS Trust

  collaborator OTHER

• North Bristol NHS Trust

  collaborator OTHER

• University of Liverpool

  collaborator OTHER

• St. George's Hospital, London

  collaborator OTHER

• Northern Care Alliance NHS Foundation Trust

  collaborator OTHER

• Burton Hospitals NHS Foundation Trust

  collaborator OTHER

• Doncaster And Bassetlaw Hospitals NHS Foundation Trust

  collaborator OTHER

• Sandwell & West Birmingham Hospitals NHS Trust

  collaborator OTHER

• London North West Healthcare NHS Trust

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Sheffield Teaching Hospitals NHS Foundation Trust

  collaborator OTHER

• University of Manchester

  lead OTHER

Principal Investigators

• Hector Chinoy, PhD FRCP · The University of Manchester

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-04

Primary Completion

2030-12-31

Completion

2030-12-31

Countries

• United Kingdom

Study Locations