16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis

Part of paid clinical trials in Boise, Idaho.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01358175
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.

Key Dates

Start date
Oct 31, 2011
Status verified
Jan 2017
Primary completion
Dec 31, 2014
Completion
Dec 31, 2014

Study Design

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

Arms

  • Experimental: Secukinumab 10 mg/kg i.v. / 75 mg s.c.
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
  • Experimental: Secukinumab 10 mg/kg i.v. / 150 mg s.c.
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
  • Placebo Comparator: Placebo
    Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.

Primary Outcome Measure

Assessment of Responders for the SpondyloArthritis International Society / ASAS 20 Response [ Time Frame: 16 weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteBoiseIdaho83702-
Novartis Investigative SiteCedar RapidsIowa52401-2112-
Novartis Investigative SitePortlandOregon97239-
Novartis Investigative SiteDuncansvillePennsylvania16635-
Novartis Investigative SiteJacksonTennessee38305-
Novartis Investigative SiteKingsportTennessee37660-
Novartis Investigative SiteAustinTexas78731-
Novartis Investigative SiteBenbrookTexas76126-
Novartis Investigative SiteDallasTexas75231-
Novartis Investigative SiteSpokaneWashington99204-

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