MYOPROSP - a Prospective Cohort Study in Myositis

NCT02468895 | Active Not Recruiting DMC

• 1 other identifier: UoMMYO
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Myositis; Idiopathic inflammatory myopathy; Antibodies; Genetics; Biomarkers

Outcome Measures

Primary Outcomes (1)

• Number of participants with a significant change levels of diagnostic biomarkers.

  This will depend on the specific biomarker/cytokine being measured

  5 years

Secondary Outcomes (2)

• Number of participants with a 20% improvement in myositis specific disease activity measures from baseline

  5 years

• Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls

  5 years

Study Arms (1)

Idiopathic Inflammatory Myopathy

PM, DM, sIBM, necrotizing myopathy, anti-synthetase syndrome, suspected myopathy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Idiopathic Inflammatory Myopathy, UK based patients

You may qualify if:

• Polymyositis
• Dermatomyositis (including amyopathic)
• 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

You may not qualify if:

• Patients with disease duration \>2 years
• Patients \< 18 years
• Confirmed non-inflammatory myopathies
• Myositis secondary to alcohol or drug abuse
• 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

Sponsors & Collaborators

• University of Manchester: lead
• University of Bath: collaborator
• University College, London: collaborator
• Royal Victoria Infirmary: collaborator
• King's College Hospital NHS Trust: collaborator
• North Bristol NHS Trust: collaborator
• University of Liverpool: collaborator
• St. George's Hospital, London: collaborator
• Northern Care Alliance NHS Foundation Trust: collaborator
• Burton Hospitals NHS Foundation Trust: collaborator
• Doncaster And Bassetlaw Hospitals NHS Foundation Trust: collaborator
• Sandwell & West Birmingham Hospitals NHS Trust: collaborator
• London North West Healthcare NHS Trust: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• Sheffield Teaching Hospitals NHS Foundation Trust: collaborator

Study Sites (1)

The University of Manchester

Manchester, Please Select, M13 9PT, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA RNA Peripheral blood mononuclear cells Serum Plasma Urine Muscle biopsies Other diagnostic tissue

MeSH Terms

Conditions

Myositis

Condition Hierarchy (Ancestors)

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

Study Officials

• Hector Chinoy, PhD FRCP

  The University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: June 11, 2015
• Study Start: October 4, 2016
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2030
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Final study data and results will be available once data clean up and study analysis has been completed. Data clean up and study analysis ongoing . To be completed before the study end date, December 2030.
• Access Criteria: Must be approved by the MYOPROSP steering Committee

Locations

GB (1)