MYOPROSP - a Prospective Cohort Study in Myositis (MYOPROSP)
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|ClinicalTrials.gov Identifier: NCT02468895|
Recruitment Status : Recruiting
First Posted : June 11, 2015
Last Update Posted : September 26, 2019
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.
|Condition or disease|
|Myositis Idiopathic Inflammatory Myopathy|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||300 participants|
|Target Follow-Up Duration:||5 Years|
|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|
|Actual Study Start Date :||October 4, 2016|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Idiopathic Inflammatory Myopathy
PM, DM, sIBM, necrotizing myopathy, anti-synthetase syndrome, suspected myopathy
- Number of participants with a significant change levels of diagnostic biomarkers. [ Time Frame: 5 years ]This will depend on the specific biomarker/cytokine being measured
- Number of participants with a 20% improvement in myositis specific disease activity measures from baseline [ Time Frame: 5 years ]As per the published International Myositis Assessment & Clinical Studies Group (IMACS) outcome measures of definition of improvement (http://www.niehs.nih.gov/research/resources/imacs/definitions/index.cfm)
- Differences in frequency of genetic variants associated with IIM and subtypes compared to population matched controls [ Time Frame: 5 years ]Specific identified genetic variants will be identified as part of large scale genetic studies
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02468895
|Contact: Hector Chinoy, PhD FRCPemail@example.com|
|The University of Manchester||Recruiting|
|Manchester, Please Select, United Kingdom, M13 9PT|
|Contact: Paul New +442755993 firstname.lastname@example.org|
|Principal Investigator:||Hector Chinoy, PhD FRCP||The University of Manchester|