NCT00988221

A Study of Tocilizumab in Patients With Active Polyarticular Juvenile Idiopathic Arthritis

A 24 Week Randomized, Double-blind, Placebo-controlled Withdrawal Trial With a 16 Week Open-label lead-in Phase, and 64 Week Open-label Follow-up, to Evaluate the Effect on Clinical Response and the Safety of Tocilizumab in Patients With Active Polyarticular-course Juvenile Idiopathic Arthritis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This 3-part study evaluated the efficacy and safety of tocilizumab in patients with active polyarticular-course juvenile idiopathic arthritis who have an inadequate response to, or were intolerant of methotrexate. In Part I of the study, all patients received intravenous (iv) infusions of tocilizumab (8 mg/kg for patients ≥ 30kg, 8 mg/kg or 10 mg/kg for patients \< 30kg) every 4 weeks for 16 weeks. In Part II of the study, patients with an adequate response in Part I were randomized to receive either tocilizumab at the same dose as in Part I or placebo every 4 weeks for up to 24 weeks. In Part III of the study, patients received tocilizumab at the same dose as in Part I every 4 weeks for up to another 64 weeks. Standard of care therapy with or without non-steroidal anti-inflammatory drugs (NSAID), corticosteroids, or methotrexate was continued throughout the study.

Conditions

• Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Tocilizumab	Tocilizumab was supplied as a sterile solution in vials.
DRUG	Placebo	Placebo to tocilizumab was supplied as a sterile solution in vials.

Timeline

• Start date: 2009-11-30
• Primary completion: 2011-11-30
• Completion: 2013-01-28
• First posted: 2009-10-02
• Last updated: 2017-07-26
• Results posted: 2012-11-01

Locations

69 sites across 15 countries: United States, Argentina, Australia, Belgium, Brazil, Canada, France, Germany, Italy, Mexico, Peru, Poland, Russia, Spain, United Kingdom