Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:September 2011
End Date:October 2014

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A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis

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


Inclusion criteria:

- Male or non-pregnant, non-lactating female patients at least 18 years of age

- Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6
months with moderate to severe PsA who must have at Baseline ≥3 tender joints out of
78 and ≥3 swollen out of 76 (dactylitis of a digit counts as one joint each)

- Rheumatoid factor and anti-CCP antibodies negative

- Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of ≥2cm
diameter or nail changes consistent with psoriasis or documented history o plaque
psoriasis

Exclusion criteria:

- Chest X-ray with evidence of ongoing infectious or malignant process

- Subjects who have previously been treated with more than 3 different TNFα inhibitors

- Subjects taking high potency opioid analgesics

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα Other protocol-defined inclusion/exclusion criteria may apply
We found this trial at
24
sites
Benbrook, Texas 76126
351
mi
from
Benbrook, TX
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Anniston, Alabama 36207
728
mi
from
Anniston, AL
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Boston, Massachusetts 02118
1444
mi
from
Boston, MA
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Caba, Buenos Aires
5602
mi
from
Caba,
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Charlotte, North Carolina 28277
962
mi
from
Charlotte, NC
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Columbia, South Carolina 29201
973
mi
from
Columbia, SC
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Dallas, Texas 75216
353
mi
from
Dallas, TX
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Duncansville, Pennsylvania 16635
1053
mi
from
Duncansville, PA
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Eagan, Minnesota 55121
546
mi
from
Eagan, MN
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Freehold, New Jersey 07728
1270
mi
from
Freehold, NJ
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Houston, Texas 77030
572
mi
from
Houston, TX
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Jackson, Tennessee 38305
520
mi
from
Jackson, TN
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Johnston, Rhode Island 02919
1418
mi
from
Johnston, RI
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Lincoln, Nebraska 68506
218
mi
from
Lincoln, NE
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Mesa, Arizona 85205
835
mi
from
Mesa, AZ
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Mesquite, Texas 75150
346
mi
from
Mesquite, TX
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Newnan, Georgia 30263
790
mi
from
Newnan, GA
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North Charleston, South Carolina 29420
1050
mi
from
North Charleston, SC
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Oklahoma City, Oklahoma 73104
158
mi
from
Oklahoma City, OK
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Paradise Valley, Arizona 85253
843
mi
from
Paradise Valley, AZ
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Richmond Heights, Missouri 63117
411
mi
from
Richmond Heights, MO
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Seattle, Washington 98103
1412
mi
from
Seattle, WA
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Tamarac, Florida 33321
1298
mi
from
Tamarac, FL
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Upland, California 91786
1135
mi
from
Upland, CA
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