This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
124
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
Chicago, Illinois, United States
Duplicate_University of Louisville /ID# 202896
Louisville, Kentucky, United States
Boston Children's Hospital /ID# 202993
Boston, Massachusetts, United States
Cincinnati Childrens Hospital Medical Center /ID# 209697
Cincinnati, Ohio, United States
Randall Children's Hospital /ID# 213609
Portland, Oregon, United States
Treatment Emergent Adverse Events (TEAEs)
Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Time frame: Up to approximately 156 weeks
Part 1: Maximum observed plasma concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Time frame: Day 7
Part 1: Time to maximum observed plasma concentration (Tmax)
Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
Time frame: Day 7
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.
Time frame: Day 7
Part 1: Apparent oral clearance at steady state (CL/F)
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time frame: Day 7
Part 1: Half-life
Half life of updadacitinib will be determined using non-compartmental method.
Time frame: Day 7
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Children's Hospital of Philadelphia /ID# 209617
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh of UPMC /ID# 202994
Pittsburgh, Pennsylvania, United States
Seattle Children's Hospital /ID# 203003
Seattle, Washington, United States
Alberta Children's Hospital /ID# 251738
Calgary, Alberta, Canada
British Columbia Children and Women's Hospital and Health Centre /ID# 251736
Vancouver, British Columbia, Canada
...and 25 more locations