CompletedPhase 3

β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)

United States136 participantsStarted 2011-11

Plain-language summary

This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Patients who have completed the second extension studies CACZ885H2356E2 or CACZ885H2357E2 * Patients treated with canakinumab in the core studies or subsequent extensions Exclusion Criteria: \- Pregnant or nursing (lactating) women

What they're measuring

Number of Incidence Rate (IR) of Adverse Events, Serious Adverse Events and Death Per 100 Patient-years in Participants

Timeframe: From start of the core studies (CACZ885H2357 [NCT01080131] and CACZ885H2361 [NCT01356602]) up to end of the current study (36 weeks)

Trial details

NCT IDNCT01470989

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-05

Results submitted2021-05-13

View on ClinicalTrials.gov More Acute Gouty Arthritis Flares trials