NCT02296424

ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab

β-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab An Open-label Canakinumab (ACZ885) Dose Reduction or Dose Interval Prolongation Efficacy and Safety Study in Patients With Systemic Juvenile Idiopathic Arthritis (SJIA)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.

Detailed description

This two-part open-label study was to assess 2 different canakinumab taper regimens in patients with clinical remission (inactive disease for at least 24 continuous weeks) on canakinumab treatment without concomitant corticosteroids (CS) or methotrexate (MTX). The study was also to collect long term safety and tolerability data on SJIA patients treated with canakinumab.

Conditions

• Systemic Juvenile Idiopathic Arthritis (SJIA)

Interventions

Type	Name	Description
DRUG	ACZ885 150 mg (Canakinumab)	Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.

Timeline

• Start date: 2014-11-17
• Primary completion: 2016-10-14
• Completion: 2017-09-25
• First posted: 2014-11-20
• Last updated: 2019-07-09
• Results posted: 2019-07-09

Locations

50 sites across 16 countries: United States, Austria, Belgium, Brazil, Canada, France, Germany, Hungary, Israel, Italy, Netherlands, Poland, Russia, Spain, Sweden, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study