24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:12/14/2018
Start Date:April 10, 2014
End Date:March 28, 2018

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A Phase III, Randomized, Double-blind, Placebo-controlled Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and Long Term Safety and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis

The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
factor alpha (TNFα) therapy.


Inclusion Criteria:

- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
Psoriatic ARthritis (CASPAR) criteria.

- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.

- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.

- Inadequate control of symptoms with NSAID.

Exclusion Criteria:

- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
infectious or malignant process.

- Subjects taking high potency opioid analgesics.

- Previous exposure to secukinumab or other biologic drug directly targeting
interleukin-17 (IL-17) or IL-17 receptor.

- Ongoing use of prohibited psoriasis treatments / medications.

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα.

- Previous treatment with any cell-depleting therapies.
We found this trial at
13
sites
Saint Louis, Missouri 63128
407
mi
from
Saint Louis, MO
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Albany, New York 12208
1307
mi
from
Albany, NY
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Austin, Texas 78759
517
mi
from
Austin, TX
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Aventura, Florida 33180
1315
mi
from
Aventura, FL
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Bowling Green, Kentucky 42101
624
mi
from
Bowling Green, KY
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Duncansville, Pennsylvania 16635
1053
mi
from
Duncansville, PA
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Freehold, New Jersey 07728
1270
mi
from
Freehold, NJ
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Indianapolis, Indiana 46202
642
mi
from
Indianapolis, IN
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Kogarah, New South Wales 2217
8655
mi
from
Kogarah,
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Mesquite, Texas 75150
346
mi
from
Mesquite, TX
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Palm Harbor, Florida 34684
1099
mi
from
Palm Harbor, FL
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Sarasota, Florida 34239
1143
mi
from
Sarasota, FL
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Wenatchee, Washington 98801
1317
mi
from
Wenatchee, WA
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