At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 52 enrolled
Drug / intervention
Tocilizumabdrug
Likely dose
Tocilizumab 162 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase Ib, Open-Label, Multicenter Study to Investigate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Following Subcutaneous Administration to Patients With Polyarticular Juvenile Idiopathic Arthritis
In Brief
A Phase 1 clinical trial evaluating Tocilizumab for Juvenile Idiopathic Arthritis. Completed, enrolled 52 participants across 35 sites in 12 countries.
Detailed Summary
This open-label, multicenter study evaluated the pharmacokinetics, pharmacodynamics and safety of SC administered TCZ in participants with pJIA.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopathic Arthritis
CountriesArgentina, Australia, Brazil, Canada, France, Germany, Italy, Mexico, Russia, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionMay 2016
TodayJul 2026
First PostedJul 22, 2013
Enrollment StartJul 1, 2013
Primary CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 12.9 years ago
Interventions
Tocilizumabdrug
Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks