CompletedPhase 3

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

United States397 participantsStarted 2011-08-25

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Participants Who Reported Adverse Events

Timeframe: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks)

Trial details

NCT IDNCT01431638

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05-09

Results submitted2021-04-06

View on ClinicalTrials.gov More Acute Gouty Arthritis trials