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
Columbia, South Carolina 29201
2105
mi
from 91732
Columbia, SC
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Anniston, Alabama 36207
1838
mi
from 91732
Anniston, AL
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Benbrook, Texas 76126
1187
mi
from 91732
Benbrook, TX
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Boston, Massachusetts 02118
2578
mi
from 91732
Boston, MA
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Caba, Buenos Aires
6113
mi
from 91732
Caba,
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Charlotte, North Carolina 28277
2104
mi
from 91732
Charlotte, NC
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Dallas, Texas 75216
1225
mi
from 91732
Dallas, TX
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Duncansville, Pennsylvania 16635
2201
mi
from 91732
Duncansville, PA
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Eagan, Minnesota 55121
1511
mi
from 91732
Eagan, MN
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Freehold, New Jersey 07728
2419
mi
from 91732
Freehold, NJ
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Houston, Texas 77030
1357
mi
from 91732
Houston, TX
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Jackson, Tennessee 38305
1653
mi
from 91732
Jackson, TN
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Johnston, Rhode Island 02919
2557
mi
from 91732
Johnston, RI
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Lincoln, Nebraska 68506
1257
mi
from 91732
Lincoln, NE
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Mesa, Arizona 85205
363
mi
from 91732
Mesa, AZ
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Mesquite, Texas 75150
1233
mi
from 91732
Mesquite, TX
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Newnan, Georgia 30263
1900
mi
from 91732
Newnan, GA
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North Charleston, South Carolina 29420
2172
mi
from 91732
North Charleston, SC
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Oklahoma City, Oklahoma 73104
1165
mi
from 91732
Oklahoma City, OK
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Paradise Valley, Arizona 85253
350
mi
from 91732
Paradise Valley, AZ
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Richmond Heights, Missouri 63117
1566
mi
from 91732
Richmond Heights, MO
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Seattle, Washington 98103
965
mi
from 91732
Seattle, WA
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Tamarac, Florida 33321
2306
mi
from 91732
Tamarac, FL
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Upland, California 91786
20
mi
from 91732
Upland, CA
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