About this trial
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participants must have completed a previous study of baricitinib for the treatment of JIA.
Disqualifiers
Participants must not have had a permanent discontinuation of baricitinib in the prior study.
Participants must have not developed an allergy to baricitinib.
Trial design
Single group
Treatments tested in this trial
Baricitinib
DrugAdministered orally.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs
Number of Participants with Permanent Investigational Product Discontinuations
Number of participants with permanent investigational product discontinuations
Secondary outcomes
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Proportion of participants achieving PedACR30
Proportion of Participants who have Disease Flare
Proportion of participants who have disease flare
Proportion of Participants with Inactive Disease
Proportion of participants with inactive disease
Proportion of Participants with Minimal Disease Activity
Proportion of participants with minimal disease activity
Sponsors and contacts
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