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

Completed · Phase 3

Conditions studied: Acute Gouty Arthritis

In brief

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.

Key facts

Study ID

NCT01431638

Run by

Novartis Pharmaceuticals

People needed

397

Starts

2011-08-25

Expected to finish

2013-05-09

Last updated by the study team

2021-07-19

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Compliance and completion of the canakinumab PFS core study
• Unchanged significant clinical medical history from entry into core study

You may not qualify if…

• Physician judgment of unsuitability for the study
• Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis Investigative Site — Gulf Shores, Alabama, United States
• Novartis Investigative Site — Mobile, Alabama, United States
• Novartis Investigative Site — Chandler, Arizona, United States
• Novartis Investigative Site — Scottsdale, Arizona, United States
• Novartis Investigative Site — Buena Park, California, United States
• Novartis Investigative Site — Norwalk, California, United States
• Novartis Investigative Site — Westlake Village, California, United States
• Novartis Investigative Site — Jupiter, Florida, United States
• Novartis Investigative Site — Largo, Florida, United States
• Novartis Investigative Site — South Miami, Florida, United States
• Novartis Investigative Site — Augusta, Georgia, United States
• Novartis Investigative Site — Decatur, Georgia, United States
• Novartis Investigative Site — Topeka, Kansas, United States
• Novartis Investigative Site — Louisville, Kentucky, United States
• Novartis Investigative Site — Owensboro, Kentucky, United States
• Novartis Investigative Site — Metairie, Louisiana, United States
• Novartis Investigative Site — Troy, Michigan, United States
• Novartis Investigative Site — Belzoni, Mississippi, United States
• Novartis Investigative Site — Jackson, Mississippi, United States
• Novartis Investigative Site — Picayune, Mississippi, United States
• Novartis Investigative Site — Missoula, Montana, United States
• Novartis Investigative Site — Lincoln, Nebraska, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Omaha, Nebraska, United States
• Novartis Investigative Site — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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