Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02798211
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

To demonstrate that the efficacy of secukinumab 300 mg at Week 16 was superior to placebo in adult patients with active PsA based on the proportion of patients achieving an American College of Rheumatology 20 (ACR20) response.

Key Dates

Start date
Jun 27, 2016
Status verified
Oct 2021
Primary completion
Dec 5, 2018
Completion
Dec 5, 2018

Study Design

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

Arms

  • Active Comparator: Group 1
    secukinumab 300mg s.c. injection
  • Active Comparator: Group 2
    secukinumab 150 mg s.c. injection
  • Placebo Comparator: Group 3
    Placebo s.c. injection

Primary Outcome Measure

Percent of Patients Achieving American College of Rheumatology Score of at Least 20% (ACR20) Response Criteria on Secukinumab 300 mg and 150 mg vs. Placebo at Week 16 [ Time Frame: 16 Weeks ]

Locations (57)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBirminghamAlabama35205-
Novartis Investigative SiteLittle RockArkansas72205-
Novartis Investigative SiteEl CajonCalifornia92020-
Novartis Investigative SiteFountain ValleyCalifornia92708-
Novartis Investigative SiteLa JollaCalifornia92093-
Novartis Investigative SiteLa MesaCalifornia91942-
Novartis Investigative SiteUplandCalifornia91786-
Novartis Investigative SiteAventuraFlorida33180-
Novartis Investigative SiteClearwaterFlorida33765-
Novartis Investigative SiteDeBaryFlorida32713-
Novartis Investigative SiteJacksonvilleFlorida32207-
Novartis Investigative SiteNorth NaplesFlorida34102-
Novartis Investigative SitePalm HarborFlorida34684-
Novartis Investigative SitePensacolaFlorida32514-
Novartis Investigative SitePlantationFlorida33324-
Novartis Investigative SiteSarasotaFlorida34239-
Novartis Investigative SiteTampaFlorida33609-
Novartis Investigative SiteTampaFlorida33613-
Novartis Investigative SiteDuluthGeorgia30096-
Novartis Investigative SiteBaltimoreMaryland21224-
Novartis Investigative SiteBostonMassachusetts02115-
Novartis Investigative SiteWorcesterMassachusetts01655-
Novartis Investigative SiteBattle CreekMichigan49015-
Novartis Investigative SiteKalamazooMichigan49008-
Novartis Investigative SiteEaganMinnesota55121-
Novartis Investigative SiteLincolnNebraska68516-
Novartis Investigative SiteLas VegasNevada89106-
Novartis Investigative SiteRidgewoodNew Jersey07450-
Novartis Investigative SiteSummitNew Jersey07901-
Novartis Investigative SiteAlbanyNew York12206-
Novartis Investigative SiteBrooklynNew York11201-
Novartis Investigative SiteLake SuccessNew York11402-
Novartis Investigative SiteOrchard ParkNew York14127-
Novartis Investigative SitePotsdamNew York13676-
Novartis Investigative SiteSaranac LakeNew York12983-
Novartis Investigative SiteCharlotteNorth Carolina28226-
Novartis Investigative SiteGreensboroNorth Carolina27408-
Novartis Investigative SiteNew BernNorth Carolina28562-
Novartis Investigative SiteMarionOhio43302-
Novartis Investigative SitePerrysburgOhio43551-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SitePhiladelphiaPennsylvania19104-
Novartis Investigative SiteCharlestonSouth Carolina29460-
Novartis Investigative SiteGreenvilleSouth Carolina29601-
Novartis Investigative SiteOrangeburgSouth Carolina29118-2475-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteArlingtonTexas76014-
Novartis Investigative SiteArlingtonTexas77373-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteDallasTexas75246-
Novartis Investigative SiteHoustonTexas77074-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteSan AntonioTexas78229-
Novartis Investigative SiteSalt Lake CityUtah84132-
Novartis Investigative SiteSeattleWashington98122-
Novartis Investigative SiteSpokaneWashington99204-

Find similar trials in Birmingham, AL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Novartis Investigative Site· Birmingham, ALNovartis Investigative Site· Little Rock, ARNovartis Investigative Site· El Cajon, CANovartis Investigative Site· Fountain Valley, CANovartis Investigative Site· La Jolla, CANovartis Investigative Site· La Mesa, CA

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