NCT01667471

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

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 9 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	tocilizumab [RoActemra/Actemra]	8 mg/kg iv every 4 weeks, 104 weeks

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-08-17
• Last updated: 2016-11-02
• Results posted: 2015-10-02

Locations

3 sites across 1 country: Germany