Safety and Efficacy of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients

Part of paid clinical trials in Anniston, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01356602
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 study assessed the safety and efficacy of canakinumab pre-filled syringes in comparison to triamcinolone acetonide 40 mg and canakinumab lyophilizate in patients that have frequent flares of acute gouty arthritis.

Key Dates

Start date
May 31, 2011
Status verified
Dec 2013
Primary completion
Sep 30, 2012
Completion
Sep 30, 2012

Study Design

Enrollment
397 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Canakinumab, pre-filled syringes (PFS)
    Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
  • Active Comparator: Canakinumab, lyophilizate (LYO)
    The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized powder and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
  • Active Comparator: Triamcinolone Acetonide
    The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.

Primary Outcome Measure

Pain Intensity on a 0-100 mm Visual Analog Scale (VAS) Between the Canakinumab 150 mg PFS and Triamcinolone Acetonide 40 mg Groups [ Time Frame: 72 hours post dose ]

Locations (69)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteAnnistonAlabama36207-5710-
Novartis Investigative SiteGulf ShoresAlabama36547-
Novartis Investigative SiteMobileAlabama36608-
Novartis Investigative SiteChandlerArizona85224-
Novartis Investigative SitePhoenixArizona85013-
Novartis Investigative SiteScottsdaleArizona85251-
Novartis Investigative SiteBuena ParkCalifornia90620-
Novartis Investigative SiteFair OaksCalifornia95628-
Novartis Investigative SiteNorwalkCalifornia90650-
Novartis Investigative SiteOrangevaleCalifornia95662-
Novartis Investigative SitePasadenaCalifornia91105-
Novartis Investigative SiteWestlake VillageCalifornia91361-
Novartis Investigative SiteClearwaterFlorida33756-
Novartis Investigative SiteJupiterFlorida33458-
Novartis Investigative SiteLargoFlorida33773-
Novartis Investigative SiteSouth MiamiFlorida33143-
Novartis Investigative SiteAugustaGeorgia30904-
Novartis Investigative SiteDecaturGeorgia30035-
Novartis Investigative SiteMeridianIdaho83642-
Novartis Investigative SiteOverland ParkKansas66215-
Novartis Investigative SiteTopekaKansas66606-
Novartis Investigative SiteLouisvilleKentucky40217-
Novartis Investigative SiteOwensboroKentucky42303-
Novartis Investigative SiteMetairieLouisiana70006-
Novartis Investigative SiteTroyMichigan48085-
Novartis Investigative SiteBelzoniMississippi39038-
Novartis Investigative SiteJacksonMississippi39202-
Novartis Investigative SiteJacksonMississippi39209-
Novartis Investigative SitePicayuneMississippi39466-
Novartis Investigative SiteMissoulaMontana59804-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteOmahaNebraska68114-
Novartis Investigative SiteOmahaNebraska68134-
Novartis Investigative SiteFreeholdNew Jersey07728-
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 SiteCharlotteNorth Carolina28277-
Novartis Investigative SiteGreensboroNorth Carolina27401-
Novartis Investigative SiteGreensboroNorth Carolina27408-
Novartis Investigative SiteSalisburyNorth Carolina28144-
Novartis Investigative SiteShelbyNorth Carolina28152-
Novartis Investigative SiteWilmingtonNorth Carolina28401-
Novartis Investigative SiteFargoNorth Dakota58103-
Novartis Investigative SiteMogadoreOhio44260-
Novartis Investigative SiteOklahoma CityOklahoma73109-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteCharlestonSouth Carolina29412-
Novartis Investigative SiteColumbiaSouth Carolina29204-
Novartis Investigative SiteGreerSouth Carolina29651-
Novartis Investigative SiteMurrells InletSouth Carolina29576-
Novartis Investigative SiteNinety SixSouth Carolina29666-
Novartis Investigative SiteVarnvilleSouth Carolina29944-
Novartis Investigative SiteBristolTennessee37620-
Novartis Investigative SiteFayettevilleTennessee33734-
Novartis Investigative SiteJohnson CityTennessee37601-
Novartis Investigative SiteMemphisTennessee38125-
Novartis Investigative SiteBedfordTexas76021-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteHoustonTexas77034-
Novartis Investigative SiteBountifulUtah84010-
Novartis Investigative SiteCharlottesvilleVirginia22911-
Novartis Investigative SiteDanvilleVirginia24541-
Novartis Investigative SiteMidlothianVirginia23114-
Novartis Investigative SiteNewport NewsVirginia23606-
Novartis Investigative SiteBellevueWashington98004-

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