CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 6 enrolled
Drug / intervention
tocilizumab [RoActemra/Actemra]drug
Likely dose
tocilizumab [RoActemra/Actemra] 8 mg/kgfrom 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.

Search/NCT01667471
NCT01667471Phase 3Completed
CompareCT.gov

Long-term, Interventional, Open Label Extension Study Evaluating the Safety of Tocilizumab Treatment in Patients With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global, Multinational Trial (WA19977)

Hoffmann-La Roche·interventional·Posted Aug 17, 2012·Updated Nov 2, 2016

In Brief

A Phase 3 clinical trial evaluating tocilizumab [RoActemra/Actemra] for Juvenile Idiopathic Arthritis. Completed, enrolled 6 participants across 3 sites.

Detailed Summary

This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsJuvenile Idiopathic Arthritis
CountriesGermany
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 17, 2012
Enrollment StartJan 1, 2012
Primary CompletionAug 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 13.9 years ago

Interventions

tocilizumab [RoActemra/Actemra]drug

8 mg/kg iv every 4 weeks, 104 weeks