Status:
COMPLETED
A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Lead Sponsor:
Eli Lilly and Company
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE3
Brief Summary
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.
Eligibility Criteria
Inclusion
- Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis \[ERA\] including JPsA).
- Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).
Exclusion
- Participants must not have systemic JIA, with or without active systemic features.
- Participants must not have persistent oligoarticular arthritis.
- Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
Key Trial Info
Start Date :
December 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03773978
Start Date
December 17 2018
End Date
January 26 2022
Last Update
October 7 2022
Active Locations (86)
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1
Instituto CAICI SRL
Rosario, Santa Fe Province, Argentina, 2000
2
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
3
Hospital General de Niños Dr. Pedro de Elizalde
Buenos Aires, Argentina, C1270AAN
4
The Sydney Children's Hospitals Network
Westmead, New South Wales, Australia, 2145