Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis (PsA) After 16 Weeks of Treatment Compared to Placebo



Status:Active, not recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:2/16/2018
Start Date:June 27, 2016
End Date:October 1, 2018

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A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Secukinumab 300 mg and 150 mg in Adult Patients With Active Psoriatic Arthritis After 16 Weeks of Treatment Compared to Placebo and to Assess the Safety, Tolerability and Efficacy up to 52 Weeks

To demonstrate that the efficacy of secukinumab 300 mg at Week 16 is superior to placebo in
adult patients with active PsA based on the proportion of patients achieving an American
College of Rheumatology 20 (ACR20) response.


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/or anti-CCP antibodies negative at screening

- A target skin psoriatic lesion and a PASI score of 1 or greater

Exclusion Criteria:

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

- Patients who ever received biologic immunomodulating agents including those targeting
TNFα, IL-6 and IL-12/23 investigational or approved
We found this trial at
61
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Greenville, South Carolina 29605
2020
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Albany, New York 12208
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Arlington, Texas 76012
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Austin, Texas 78759
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Aventura, Florida 33180
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Baltimore, Maryland 21287
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Battle Creek, Michigan 49015
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Birmingham, Alabama 35209
1785
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Boston, Massachusetts 02118
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Brooklyn, New York 11218
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Charlotte, North Carolina 28277
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Clearwater, Florida 33756
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Dallas, Texas 75216
1225
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Debary, Florida 32713
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Duluth, Georgia 30096
1930
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
1511
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Eagan, MN
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El Cajon, California 92020
106
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Fountain Valley, California 92708
25
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Greensboro, North Carolina 27401
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Houston, Texas 77030
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Jackson, Tennessee 38305
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Jacksonville, Florida 32216
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Kalamazoo, Michigan 49048
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La Jolla, California 92037
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La Mesa, California 91942
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Lake Success, New York 10042
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Las Vegas, Nevada 89135
217
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Lincoln, Nebraska 68506
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Little Rock, Arkansas 72204
1458
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Marion, Ohio 43302
1955
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Mesquite, Texas 75150
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New Bern, North Carolina 28562
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230 Park Avenue, 21st Floor
New York, New York 10169
1-888-669-6682)
Novartis Novartis, which was created in 1996 by the merger of the Swiss companies Ciba-Geigy...
2435
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North Charleston, South Carolina 29420
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North Naples, Florida 34102
2218
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Orangeburg, South Carolina 29115
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Orchard Park, New York 14127
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Palm Harbor, Florida 34684
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Pensacola, Florida 32504
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Perrysburg, Ohio 43551
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Philadelphia, Pennsylvania 19102
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Plantation, Florida 33324
2308
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44 Pierrepont Avenue
Postdam, New York 13676
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Providence, Rhode Island 02908
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Ridgewood, New Jersey 07450
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Salt Lake City, Utah 84103
570
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San Antonio, Texas 78207
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Santurce, 00909
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Saranac Lake, New York 12983
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Sarasota, Florida 34239
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Seattle, Washington 98103
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South Miami, Florida 33143
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Spokane, Washington 99202
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Sugar Land, Texas 77478
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Summit, New Jersey 07901
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Tampa, Florida 33613
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Torrance, California 90502
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Tustin, California 92780
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Upland, California 91786
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Worcester, Massachusetts 01665
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