MYOJAK
Research type
Research Study
Full title
A randomised, phase IIa treatment delayed-start trial of the oral JAK 1/2 inhibitor, baricitinib, in the treatment of adult idiopathic inflammatory myopathy
IRAS ID
273307
Contact name
Helen Bradley
Contact email
Sponsor organisation
University of Manchester
Eudract number
2019-003868-42
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
We are carrying out this research in order to investigate better ways of treating patients diagnosed with adult idiopathic inflammatory myositis (IIM).
IIM is a rare condition that primarily affects the muscles and is believed to be caused by an underlying problem with the immune system in which it mistakenly attacks healthy tissue. This leads to inflammation of the muscles and other parts of the body, and progressive muscle weakness. Previous studies indicate that a new group of drugs, called Janus Kinase Inhibitors or ‘JAKs’ may be beneficial in treating this group of patients.
JAKs work by reducing the activity of an enzyme in the body called ‘Janus Kinase’ which is involved in inflammation. In this way, JAKs may help to prevent, or minimize, damage to muscles and other tissues that occurs in patients with IIM. These positive effects could help patients carry out day-to-day activities and improve health-related quality of life.
This study will be testing the clinical effect of the Janus Kinase Inhibitor, baricitinib. Patients will attend hospital approximately 11 times over 40 weeks in order to complete all necessary study assessments. The first visit will screen patients for suitability, after which patients will be randomly allocated into one of two treatment arms and will attend a baseline visit.
Patients randomised to the immediate-start arm will receive baricitinib for 24 weeks from the baseline visit. The other half (delayed-start arm) will wait 12 weeks before being prescribed the drug, again for a total of 24 weeks.
Blood and urine samples will be taken at various visits for research purposes. These samples will be used to undertake analyses of the immune system and to look for disease-specific markers. The knowledge gained from this analysis will help the investigators to learn more about the disease and the therapeutic effectiveness of baricitinib.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
20/NW/0138
Date of REC Opinion
19 May 2020
REC opinion
Further Information Favourable Opinion