NCT00891046

An Open-label Extension Study of Canakinumab in Patients With Systemic Juvenile Idiopathic Arthritis and Active Systemic Manifestations Manifestations and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever.

An Open-label Extension Study of Canakinumab (ACZ885) in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations Who Participated in Studies ACZ885G2301 and ACZ885G2305; and Response Characterization Study in Canakinumab Treatment-naïve Patients With Active SJIA With and Without Fever

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 270 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This open-label extension study will permit patients with Systemic Juvenile Idiopathic Arthritis (SJIA) who previously were responsive to treatment with canakinumab and canakinumab treatment-naïve patients with active SJIA with and without fever to be retreated with 4 mg/kg s.c. every 4 weeks and assessed for continued efficacy and safety until discontinuation or when study CACZ885G2402 is in place at their study center or around March 2013, whichever occurs first. Patients who are steroid-free will be able to taper their canakinumab dose to 2 mg/kg s.c. every 4 weeks.

Conditions

• Systemic Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab	Canakinumab

Timeline

• Start date: 2009-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-04-30
• Last updated: 2019-03-26
• Results posted: 2017-03-10

Locations

73 sites across 21 countries: United States, Argentina, Austria, Belgium, Brazil, Canada, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Peru, Poland, Russia, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom