Limitations, agreements, and source contact

Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicine Including a 12 Weeks Extension and an Open-label 48 Weeks Extension Study · Source last updated 2014-01-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

certain Agreement

other Details

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.

pi Sponsor Employee

false

restriction Type

OTHER

restrictive Agreement

true

limitations And Caveats

description

Bioanalytical results: With analytical method used, anti-canakinumab antibodies were detected in 10 patients. However, no patients showed any unexpected PK/ PD profile nor had adverse events suggestive of immunogenicity.

point Of Contact

organization

Novartis Pharmaceuticals

phone

862 778-8300

title

Study Director

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice