At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 25 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
Adalimumab 20 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 Multicenter, Open-label Study of the Safety, Efficacy, and Pharmacokinetics of the Human Anti-TNF Monoclonal Antibody Adalimumab in Children With Polyarticular Juvenile Rheumatoid Arthritis
In Brief
A Phase 3 clinical trial evaluating Adalimumab for Juvenile Rheumatoid Arthritis. Completed, enrolled 25 participants across 12 sites.
Detailed Summary
To evaluate efficacy, safety and pharmacokinetics of adalimumab in Japanese children with Polyarticular Juvenile Rheumatoid Arthritis
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Rheumatoid Arthritis
CountriesJapan
CollaboratorsEisai Co., Ltd.
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedJun 2008
Primary CompletionMar 2010
Study CompletionSep 2011
TodayJul 2026
First PostedJun 4, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2010
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 18.1 years ago
Interventions
Adalimumabbiological
Adalimumab administered subcutaneously every other week, with dosage determined by body weight at study entry (20 mg for children weighing less than 30 kg, 40 mg for children weighing 30 kg or more).