NCT00886769

Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)

A Randomized, Double-blind, Placebo Controlled, Single-dose Study to Assess the Initial Efficacy of Canakinumab (ACZ885) With Respect to the Adapted ACR Pediatric 30 Criteria in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA) and Active Systemic Manifestations

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 84 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare. Response to treatment will be according to the adapted American College of Rheumatology(ACR)Pediatric 30 criteria at Day 15.

Conditions

• Systemic Juvenile Idiopathic Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab	Canakinumab was supplied in individual 6 mL glass vials each containing 150 mg canakinumab powder as a lyophilized cake. Each reconstituted vial provided 150mg of canakinumab per 1 mL.
DRUG	Placebo	Placebo was provided in individual 6 mL glass vials each containing 150 mg placebo powder matching canakinumab as a lyophilized cake. Each reconstitued vial provided 150mg of placebo per 1 mL.

Timeline

• Start date: 2009-07-01
• Primary completion: 2010-12-01
• Completion: 2011-01-01
• First posted: 2009-04-23
• Last updated: 2017-03-29
• Results posted: 2012-04-09

Locations

91 sites across 22 countries: United States, Argentina, Belgium, Brazil, Canada, Denmark, France, Germany, Greece, Hungary, Israel, Italy, Netherlands, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom