Status:
COMPLETED
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Acute Gouty Arthritis
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief 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.
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Compliance and completion of the canakinumab PFS core study
- Unchanged significant clinical medical history from entry into core study
- Exclusion criteria:
- Physician judgment of unsuitability for the study
- Pregnant or nursing women Other protocol-defined inclusion/exclusion criteria may apply
Exclusion
Key Trial Info
Start Date :
August 25 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 9 2013
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT01431638
Start Date
August 25 2011
End Date
May 9 2013
Last Update
July 19 2021
Active Locations (68)
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1
Novartis Investigative Site
Anniston, Alabama, United States, 36207-5710
2
Novartis Investigative Site
Gulf Shores, Alabama, United States, 36547
3
Novartis Investigative Site
Mobile, Alabama, United States, 36608
4
Novartis Investigative Site
Chandler, Arizona, United States, 85224