This is a multi-center, open-label single-arm study to investigate the pharmacokinetics and safety of tocilizumab (RoActemra/Actemra) in participants less than 2 years old with active sJIA. Participants will receive tocilizumab infusions every 2 weeks. The anticipated time on study treatment is 12 weeks (Main evaluation period). Participants will have the option to continue tocilizumab treatment until participant reaches 2 years of age or up to one year from baseline, whichever is longer. An optional extension period will follow the main evaluation period.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Tocilizumab will be administered as indicated in the arm description.
Children's National Medical Center; Pediatric Rheumatology
Washington D.C., District of Columbia, United States
The University of Chicago;Department of Pediatrics
Chicago, Illinois, United States
University of Louisville Research Foundation, Inc; Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States
The Floating Hospital for Children at Tufts Medical Center
Boston, Massachusetts, United States
Children's Hospital Boston Pediatric Medicine
Boston, Massachusetts, United States
Children's Speciality Center of Nevada
Las Vegas, Nevada, United States
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, United States
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, United States
Children's Hospital Of Pittsburgh
Pittsburgh, Pennsylvania, United States
Hospital Gral de Niños Pedro Elizalde
Buenos Aires, Argentina
...and 10 more locations
Maximum Serum Concentration (Cmax) of Tocilizumab
Pharmacokinetic profile of tocilizumab is evaluated in terms of model predicted Cmax at steady state. Pharmacokinetic-evaluable population includes all participants who provided at least one serum pharmacokinetic sample with valid concentration data.
Time frame: Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour)
Minimum Serum Concentration (Cmin) of Tocilizumab
Pharmacokinetic profile of tocilizumab is evaluated in terms of observed Cmin at day 85. Pharmacokinetic-evaluable population.
Time frame: Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour)
Model predicted Area Under the Serum Concentration-Time Curve from Time Zero to End of Dosing (AUCtau) of Tocilizumab
AUCtau is the model-predicted area under the tocilizumab serum concentration versus time curve from time zero to the end of dosing interval (2 weeks). Pharmacokinetic-evaluable population.
Time frame: Pre-infusion (Hour 0) on Days 1, 15, 29, 43, 57, 71, and 85; at the end of infusion on Days 1, 29 and 71; and anytime on Days 8, 36, and 78 (infusion length = 1 hour)
Number of Participants With Adverse Events (AEs) and Serious AEs
Time frame: Baseline up to end of the study (up to approximately 60 weeks)
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