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

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01431638
Phase
PHASE3
Status
Completed

Conditions

  • Acute Gouty Arthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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 Dates

Start date
Aug 25, 2011
Status verified
Jun 2021
Primary completion
May 9, 2013
Completion
May 9, 2013

Study Design

Enrollment
397 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab 150mg
    Canakinumab 150mg in prefilled syringe subcutaneously

Primary Outcome Measure

Number of Participants Who Reported Adverse Events [ Time Frame: From start of the core study (CACZ885H2361 [NCT01356602]) upto end of the current study (48 weeks) ]

Locations (54)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAnnistonAlabama36207-5710-
Novartis Investigative SiteGulf ShoresAlabama36547-
Novartis Investigative SiteMobileAlabama36608-
Novartis Investigative SiteChandlerArizona85224-
Novartis Investigative SiteScottsdaleArizona85251-
Novartis Investigative SiteBuena ParkCalifornia90620-
Novartis Investigative SiteNorwalkCalifornia90650-
Novartis Investigative SiteWestlake VillageCalifornia91361-
Novartis Investigative SiteJupiterFlorida33458-
Novartis Investigative SiteLargoFlorida33773-
Novartis Investigative SiteSouth MiamiFlorida33143-
Novartis Investigative SiteAugustaGeorgia30904-
Novartis Investigative SiteDecaturGeorgia30035-
Novartis Investigative SiteTopekaKansas66606-
Novartis Investigative SiteLouisvilleKentucky40217-
Novartis Investigative SiteOwensboroKentucky42303-
Novartis Investigative SiteMetairieLouisiana70006-
Novartis Investigative SiteTroyMichigan48085-
Novartis Investigative SiteBelzoniMississippi39038-
Novartis Investigative SiteJacksonMississippi39209-
Novartis Investigative SitePicayuneMississippi39466-
Novartis Investigative SiteMissoulaMontana59804-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteOmahaNebraska68114-
Novartis Investigative SiteOmahaNebraska68134-
Novartis Investigative SiteMineolaNew York11501-
Novartis Investigative SiteNew Hyde ParkNew York11042-
Novartis Investigative SiteRoslynNew York11576-
Novartis Investigative SiteAshevilleNorth Carolina28801-
Novartis Investigative SiteCaryNorth Carolina27518-
Novartis Investigative SiteCharlotteNorth Carolina28209-
Novartis Investigative SiteGreensboroNorth Carolina27401-
Novartis Investigative SiteSalisburyNorth Carolina28144-
Novartis Investigative SiteShelbyNorth Carolina28152-
Novartis Investigative SiteWilmingtonNorth Carolina28401-
Novartis Investigative SiteFargoNorth Dakota58103-
Novartis Investigative SiteMogadoreOhio44260-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteCharlestonSouth Carolina29412-
Novartis Investigative SiteColumbiaSouth Carolina29204-
Novartis Investigative SiteFort MillSouth Carolina29707-
Novartis Investigative SiteGreerSouth Carolina29651-
Novartis Investigative SiteVarnvilleSouth Carolina29944-
Novartis Investigative SiteBristolTennessee37620-
Novartis Investigative SiteJohnson CityTennessee37601-
Novartis Investigative SiteMemphisTennessee38125-
Novartis Investigative SiteBedfordTexas76021-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteLeague CityTexas77573-
Novartis Investigative SiteBountifulUtah84010-
Novartis Investigative SiteDanvilleVirginia24541-
Novartis Investigative SiteMidlothianVirginia23114-
Novartis Investigative SiteNewport NewsVirginia23606-
Novartis Investigative SiteBellevueWashington98007-

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