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
Palm Harbor, Florida 34684
1182
mi
from 02139
Palm Harbor, FL
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Novartis Investigative Site
Aalst,
3455
mi
from 02139
Aalst,
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Novartis Investigative Site
Albany, New York 12208
138
mi
from 02139
Albany, NY
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Novartis Investigational Site
Austin, Texas 78759
1691
mi
from 02139
Austin, TX
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Novartis Investigational Site
Charleston, South Carolina 29407
818
mi
from 02139
Charleston, SC
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Novartis Investigative Site
Duncansville, Pennsylvania 16635
402
mi
from 02139
Duncansville, PA
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Novartis Investigative Site
Jackson, Tennessee 38305
1056
mi
from 02139
Jackson, TN
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Novartis Investigative Site
Mesa, Arizona 85205
2275
mi
from 02139
Mesa, AZ
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Novartis Investigative Site
Mesquite, Texas 75150
1537
mi
from 02139
Mesquite, TX
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Novartis Investigative Site
Mobile, Alabama 36693
1242
mi
from 02139
Mobile, AL
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
1489
mi
from 02139
Oklahoma City, OK
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
1489
mi
from 02139
Oklahoma City, OK
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Novartis Investigative Site
Passaic, New Jersey 07055
187
mi
from 02139
Passaic, NJ
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Novartis Investigative Site
Pembroke Pines, Florida 33024
1241
mi
from 02139
Pembroke Pines, FL
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Novartis Investigative Site
Peoria, Arizona 85381
2295
mi
from 02139
Peoria, AZ
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Novartis Investigative Site
Upland, California 91786
2557
mi
from 02139
Upland, CA
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