This study aims to investigate the clinical efficacy of baricitinib in patients with adult
idiopathic inflammatory myositis (IIM). Half of the patients enrolled onto the study will
receive 24 weeks of baricitinib from the baseline visit with a 12 week follow-up period. The
other half of patients will receive 24 weeks of barcitinib treatment after an initial 12-week
delay with a 4 week follow up period for safety.
Potential participants will attend a screening visit to confirm their eligibility to
participate in the trial. Once eligibility is confirmed the participant will be randomised to
receive 24 weeks of baracitinib from the baseline visit with 12 weeks of follow up or receive
24 weeks of baracitinib after a delayed-start of 12 weeks from the baseline visit.
Participants will attend study visits every 4 weeks starting at the baseline visit at week 0.
At each visit data will be collected about the following:
Signs of disease activity
A blood test to check blood count, liver and kidney function and markers of inflammation
for safety purposes.
Participant reported assessment of how disease disease is progressing.
In addition the following data will be collected at week 0, week 12, week 24 and week 36:
Signs of disease damage
Blood and urine sample collection for biomarker analysis
Additional muscle function and disease activity assessments
Participant reported assessment of how disease affects their day-to-day life.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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