NCT01431638

Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

A 36-week Open-label Extension Study of CACZ885H2361 on the Safety and Tolerability of Canakinumab 150 mg s.c. Pre-filled Syringe (PFS) in 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 is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.

Conditions

• Acute Gouty Arthritis

Interventions

Type	Name	Description
DRUG	Canakinumab 150mg in prefilled syringe	Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares

Timeline

• Start date: 2011-08-25
• Primary completion: 2013-05-09
• Completion: 2013-05-09
• First posted: 2011-09-09
• Last updated: 2021-07-19
• Results posted: 2021-07-19

Locations

68 sites across 4 countries: United States, Canada, Germany, Lithuania