MYOPROSP - a Prospective Cohort Study in Myositis
Key facts
- Who runs it
- University of Manchester
- Where
- United Kingdom1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- People taking part
- 300 people, planned
- Started
- 4 Oct 2016
- Expected to end
- Dec 2030
- Type of study
- Observational
- Record updated
- 3 April 2025
Who can take part
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 26 criteriaShow less
Who can take part
- Polymyositis
- Dermatomyositis (including amyopathic)
- Inclusion body myositis
- Anti-synthetase syndrome
- Myositis overlapping with another connective tissue disorder
- Cancer-associated myositis
- Immune-mediated necrotising myopathy including statin-induced myositis
- Juvenile myositis persisting into adulthood
- Fasciitis including eosinophilic myofasciitis
- Vasculitis affecting muscle
- Granulomatous myositis
- Focal myositis
- Orbital myositis
- Suspected myositis under investigation
- CTD features in association with a myositis specific / associated antibody
Who cannot take part
- Myositis secondary to alcohol or drug abuse
- Patients with disease duration >2 years
- Patients < 18 years
- Confirmed non-inflammatory myopathies
- Patients unwilling or unable to give consent
- Patients with poor or no venous access
- Patients where MR imaging is contraindicated (for MR substudy); Study population description Patients referred to tertiary level UK myositis clinics; Sampling methods N/A, this is a prospective study of consecutive eligible patients
Other criteria
- Gender Both female and males
- Age limits Patients >/= 18 years
- Accept healthy volunteers No
- Eligibility criteria
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The group in the trial
- Idiopathic Inflammatory Myopathy
PM, DM, sIBM, necrotizing myopathy, anti-synthetase syndrome, suspected myopathy
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- MYOPROSP: A Prospective Cohort Study to Identify a Stratified Approach in the Diagnosis, Treatment and Delivery of Care in Adult Idiopathic Inflammatory Myopathy
- Record updated
- 3 April 2025