drugset / Trial / NCT01727986

An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study

NCT01727986 ↗

Phase 3 Completed 11 enrolled Hoffmann-La Roche
Open-labelTreatment

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.

Timeline

Start
2013-03
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Tocilizumab Monoclonal antibody 8 mg/kg Intravenous
Subject Tocilizumab Monoclonal antibody 10 mg/kg Intravenous