NCT01727986

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 11 (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 or 10 mg/kg iv every 4 weeks, 104 weeks

Timeline

• Start date: 2013-03-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2012-11-16
• Last updated: 2016-05-05

Locations

4 sites across 1 country: Brazil