16-week Efficacy and 2-year Safety, Tolerability and Efficacy of Secukinumab in Participants With Active Psoriatic Arthritis



Status:Completed
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/6/2018
Start Date:May 29, 2015
End Date:December 19, 2017

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A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab (150 mg) in Pre-filled Syringe, With or Without Loading Regimen, to Demonstrate Efficacy, Safety and Tolerability up to 2 Years in Patients With Active Psoriatic Arthritis (FUTURE 4)

The purpose of this study was to provide 16-week efficacy, safety and tolerability data
versus placebo to support the use of secukinumab 150 mg by subcutaneous (s.c.)
self-administration with or without a loading regimen and maintenance dosing using pre-filled
syringe (PFS) and to assess efficacy, safety and tolerability up to 2 years in subjects with
active PsA despite current or previous NSAID or DMARD 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.

- Other protocol-defined inclusion criteria do apply.

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
21
sites
Palm Harbor, Florida 34684
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Palm Harbor, FL
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Albany, New York 12208
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Albany, NY
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Burlington, Vermont 05401
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Burlington, VT
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Charleston, South Carolina 29407
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Charleston, SC
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Denver, Colorado 80262
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Denver, CO
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Greenville, South Carolina 29605
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Greenville, SC
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Kogarah, New South Wales 2217
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Kogarah,
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Lincoln, Nebraska 68506
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Lincoln, NE
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Mesa, Arizona 85205
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Mesa, AZ
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Mesquite, Texas 75150
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Mesquite, TX
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Oklahoma City, Oklahoma 73104
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Oklahoma City, OK
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Peoria, Illinois 61615
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Peoria, IL
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Saint Clair Shores, Michigan 48081
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Saint Clair Shores, MI
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Sarasota, Florida 34239
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Sarasota, FL
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Seattle, Washington 98103
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Seattle, WA
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Seattle, Washington 98103
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Seattle, WA
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Shreveport, Louisiana 71101
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Shreveport, LA
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Upland, California 91786
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Upland, CA
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