At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 219 enrolled
Drug / intervention
Abataceptbiological
Likely dose
Not stated in 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 3 Multi-center, Open-Label Study to Evaluate Pharmacokinetics, Efficacy and Safety of Abatacept Administered Subcutaneously (SC) in Children and Adolescents With Active Polyarticular Juvenile Idiopathic Arthritis (pJIA) and Inadequate Response (IR) to Biologic or Non Biologic Disease Modifying Anti-rheumatic Drugs (DMARDs)
In Brief
A Phase 3 clinical trial evaluating Abatacept for Active Polyarticular Juvenile Idiopathic Arthritis. Completed, enrolled 219 participants across 57 sites in 12 countries.
Detailed Summary
The purpose of this study is to estimate Abatacept steady-state trough concentration (Cmin) at Day 113 in children and adolescents with pJIA
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Belgium, Brazil, France, Germany, Italy, Mexico, Peru, Russia, South Africa, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 2013
Enrollment StartAug 2013
Primary CompletionMar 2015
Study CompletionFeb 2023
TodayJul 2026
First PostedMay 1, 2013
Enrollment StartAug 30, 2013
Primary CompletionMar 12, 2015
Study CompletionFeb 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 13.2 years ago
Interventions
Abataceptbiological