16-week Efficacy and 3-year Safety, Tolerability and Efficacy of Secukinumab in Active Ankylosing Spondylitis Patients



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:1/10/2019
Start Date:January 14, 2014
End Date:December 11, 2017

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind, Placebo-controlled Phase III Study of Secukinumab to Demonstrate the Efficacy at 16 Weeks and to Assess the Long-term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Ankylosing Spondylitis

The purpose of this study was to generate 16-week efficacy data, as well as up to 3-year
efficacy, safety and tolerability data in subjects with active AS despite current or previous
NSAID, DMARD and/or anti-TNF therapy.


Inclusion criteria: moderate to severe AS, prior radiographic evidence according to the
Modified NY Criteria (1984), inadequate response to NSAIDs. -- Exclusion criteria:
pregnancy or lactation, on-going infectious or malignant process on a chest X-ray or MRI,
previous exposure to IL-17 or IL-17R targeting therapies, previous exposure to any
biological immunomodulating agent excluding TNF antagonists, previous cell depleting
therapy.
We found this trial at
16
sites
Novartis Investigative Site
Aalst,
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Aalst,
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Novartis Investigative Site
Albany, New York 12208
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Albany, NY
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Novartis Investigational Site
Austin, Texas 78759
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Austin, TX
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Novartis Investigational Site
Charleston, South Carolina 29407
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Charleston, SC
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Novartis Investigative Site
Duncansville, Pennsylvania 16635
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Duncansville, PA
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Novartis Investigative Site
Jackson, Tennessee 38305
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Jackson, TN
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Novartis Investigative Site
Mesa, Arizona 85205
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Mesa, AZ
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Novartis Investigative Site
Mesquite, Texas 75150
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Mesquite, TX
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Novartis Investigative Site
Mobile, Alabama 36693
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Mobile, AL
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Novartis Investigative Site
Palm Harbor, Florida 34684
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Palm Harbor, FL
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Novartis Investigative Site
Passaic, New Jersey 07055
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Passaic, NJ
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Novartis Investigative Site
Pembroke Pines, Florida 33024
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Pembroke Pines, FL
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Novartis Investigative Site
Peoria, Arizona 85381
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Peoria, AZ
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Novartis Investigative Site
Upland, California 91786
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Upland, CA
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