This Phase IV, multicenter, single-arm, open-label study will evaluate the efficacy and safety of tocilizumab in Chinese participants with sJIA with persistent activity and an inadequate response to non-steroidal anti-inflammatory drugs (NSAIDs) and steroid therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
Tocilizumab will be administered as per the schedule specified in the arm description.
Participants may receive NSAIDs up to the maximum recommended stable daily dose. Study protocol does not enforce any particular NSAID.
Participants may receive CSs at a stable dose of 30 milligrams per day (mg/day) or 0.5 milligrams per kilogram per day (mg/kg/day), whichever is less. Study protocol does not enforce any particular CS.
Capital Institute of Pediatrics
Beijing, China
Beijing Children's Hospital, Capital Medical University; rheumatism
Beijing, China
The First Hospital of Jilin University
Changchun, China
Percentage of Participants Achieving Juvenile Idiopathic Arthritis (JIA) American College of Rheumatology (ACR) 30 (JIA ACR30) Response With Absence of Fever, at Week 12
Time frame: Week 12
Percentage of Participants Achieving JIA ACR30 Response With Absence of Fever, at Week 52
Time frame: Week 52
Percentage of Participants With 30 Percent (%), 50%, 70%, and 90% Improvement From Baseline in JIA Core Set Parameters
Time frame: Baseline, Weeks 12, 24, and 52
Percentage of Participants With Inactive Disease Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria)
Time frame: Weeks 24 and 52
Percentage of Participants With Clinical Remission Assessed According to Criteria for Inactive Disease and Clinical Remission of sJIA (Wallace et. al. 2011 Criteria)
Time frame: Week 52
Percentage of Participants With an Elevated High-Sensitivity C-Reactive Protein (hsCRP) Levels at Baseline Who Have Normal hsCRP Levels at Weeks 12, 24, and 52
Time frame: Baseline, Weeks 12, 24, and 52
Mean Glucocorticoid Dose
Time frame: Baseline up to Week 52
Mean Methotrexate (MTX) Dose
Time frame: Baseline up to Week 52
Change From Baseline in Glucocorticoid Dose
Time frame: From Baseline to Week 52
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Participants may receive MTX at a stable dose of less than or equal to (\</=) 20 milligrams per square meter (mg/m\^2).
Children's Hospital Chongqing Medical university
Chongqing, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University; Pediatric Rheumatology division
Guangzhou, China
The Children's Hospibal ZheJiang University School of Medicine
Hangzhou, China
Chilren's hospital of nanjing medical university; Rheumatoid immunology
Nanjing, China
Shanghai Children's Medical Center; Renal rheumatology
Shanghai, China
Children's Hospital of Fudan University
Shanghai, China
The Second Affiliated Hospital & Yuying Children's Hospital of Wenzhou Medical College
Wenzhou, China
Change From Baseline in MTX Dose
Time frame: From Baseline to Week 52
Pain Visual Analog Scale (VAS) Score
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Change From Baseline in Pain VAS Score
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
Percentage of Participants Who Discontinue Permitted Concomitant Medication for sJIA
Time frame: Baseline up to Week 52
Percentage of Participants With Adverse Events (AEs)
Time frame: Baseline up to end of study (up to Week 60)