This open-label, multicenter study will evaluate the pharmacokinetics, pharmacodynamics, and safety of subcutaneously administered tocilizumab in participants with Systemic Juvenile Idiopathic Arthritis (sJIA). Participants with body weight less than (\<) 30 kilograms (kg) will receive subcutaneous (SC) tocilizumab dose every 2 weeks (Q2W) and participants with body weight greater than or equal to (\>=) 30 kg will receive weekly (QW), for 52 weeks. Tocilizumab was administered every 10 days until pre-planned interim analysis was performed and changed to Q2W in participants with body weight \<30 kg.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Subcutaneous 162 mg dose QW or Q2W for 52 weeks
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Connecticut Children's Medical Center; 5E Clinical Trials Unit
Hartford, Connecticut, United States
Ann & Robert H. Lurie Children's Hospital of Chicago; Division of Rheumatology
Chicago, Illinois, United States
The University of Chicago;Department of Pediatrics
Chicago, Illinois, United States
Hackensack University Medical Center; Pediatric Rheumatology
Hackensack, New Jersey, United States
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC) of Tocilizumab
Time frame: Age <2 years: 0 hours(h) on Days(D) 0,84; on D5,14,42,70,85,88,98,182,266, 364. Weight <30kg, Age>=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266, 364
Pharmacokinetics: Maximum Plasma Concentration (Cmax) of Tocilizumab
Time frame: Age <2 years: 0h on D0,84; on D5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on D0,84; on D2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30 kg: 0,6,12h on D0, 91; on D2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacokinetics: Minimum Plasma Concentration (Cmin) of Tocilizumab
Time frame: Weight <30 kg: predose (0h) on Days 0 and 84. Weight >= 30 kg: predose (0h) on Days 0 and 91
Pharmacodynamics: Serum Interleukin-6 (IL6) Levels
Time frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Soluble IL-6 Receptor (sIL-6R) Levels
Time frame: Age<2 years: 0h on Days 0,84; Days 5,14,42,70,85,88,98,182,266,364. Weight <30 kg, Age >=2 years: 0,6,12h on Days 0,84; Days 2,5,14,42,56,70,86,87,88,90,98,182,266,364. Weight >=30kg: 0,6,12h on Days 0,91;Days 2,4,7,14,28,56,92,93,95,96,98,182,266,364
Pharmacodynamics: Serum C-Reactive Protein (CRP) Levels
Time frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Serum Erythrocyte Sedimentation Rate (ESR)
Time frame: Age <2years: Days 0,14,28,42,70,84,98,126, 154,182,210,238,266,294,322,350,364. Weight <30 kg, Age >=2years: Days 0,14,28,42,70, 98,126,154,182,210,238,266,294,322,350,364. Weight >=30kg: Days 0,7,14,21,28,42, 56,70,84,91,95,96,98,182,266,294,322,350,364
Pharmacodynamics: Percentage of Participants with Anti-Tocilizumab Antibodies
Time frame: Age <2 years: Days 0, 84, 182, 266, 364. Weight <30 kg, Age >=2 years: Days 0, 84, 182, 266, 364. Weight >=30 kg: Days 0, 91, 182, 266, 364
Safety: Percentage of Participants with At Least 1 Adverse Event
Time frame: 57 weeks
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Levine Children's Hospital; Divison of Pediatric Rheumatology; Department of Pediatrics
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children'S Hospital Medical Center; Division of Rheumatology
Cincinnati, Ohio, United States
Cleveland Clinic Fndn
Cleveland, Ohio, United States
University of Utah; Immunology/Rheumatology/Allergy
Salt Lake City, Utah, United States
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