NCT01356602

Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

A Randomized, Double-blind, Active-controlled Study of Canakinumab Prefilled Syringes or Reconstituted Lyophilizate Versus Triamcinolone Acetonide for Treating Acute Gouty Arthritis Flares in Frequently Flaring Patients

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 397 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

This study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Conditions

• Acute Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab pre-filled syringe	Canakinumab pre-filled syringe
DRUG	Canakinumab lyophilized powder	Canakinumab lyophilized powder
DRUG	Triamcinolone Acetonide	Triamcinolone Acetonide
DRUG	Placebo	Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide

Timeline

• Start date: 2011-05-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2011-05-19
• Last updated: 2014-01-29
• Results posted: 2014-01-29

Locations

99 sites across 5 countries: United States, Canada, Germany, Hungary, Lithuania