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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Trial Summary
Trial Overview
Inclusion Criteria

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
Novartis Investigative Site
Mesquite, Texas 75150
1685
mi
from 98109
Mesquite, TX
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Novartis Investigative Site
Albany, New York 12208
2351
mi
from 98109
Albany, NY
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Novartis Investigative Site
Burlington, Vermont 05401
2326
mi
from 98109
Burlington, VT
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Novartis Investigational Site
Charleston, South Carolina 29407
2423
mi
from 98109
Charleston, SC
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Novartis
Denver, Colorado 80262
1023
mi
from 98109
Denver, CO
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Novartis Investigative Site
Duncansville, Pennsylvania 16635
2206
mi
from 98109
Duncansville, PA
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Novartis Investigative Site
Greenville, South Carolina 29605
2229
mi
from 98109
Greenville, SC
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Novartis Investigative Site
Kogarah, New South Wales 2217
7756
mi
from 98109
Kogarah,
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Novartis Investigative Site
Lincoln, Nebraska 68506
1350
mi
from 98109
Lincoln, NE
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Novartis Investigative Site
Mesa, Arizona 85205
1126
mi
from 98109
Mesa, AZ
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
1523
mi
from 98109
Oklahoma City, OK
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Novartis Investigative Site
Oklahoma City, Oklahoma 73104
1523
mi
from 98109
Oklahoma City, OK
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Novartis Investigative Site
Palm Harbor, Florida 34684
2509
mi
from 98109
Palm Harbor, FL
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Novartis Investigative Site
Peoria, Illinois 61615
1672
mi
from 98109
Peoria, IL
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Novartis Investigative Site
Saint Clair Shores, Michigan 48081
1935
mi
from 98109
Saint Clair Shores, MI
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Novartis Investigative Site
Saint Louis, Missouri 63128
1717
mi
from 98109
Saint Louis, MO
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Novartis Investigative Site
Sarasota, Florida 34239
2554
mi
from 98109
Sarasota, FL
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Novartis Investigative Site
Seattle, Washington 98103
1
mi
from 98109
Seattle, WA
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Novartis Investigative Site
Seattle, Washington 98103
1
mi
from 98109
Seattle, WA
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Novartis Investigative Site
Shreveport, Louisiana 71101
1820
mi
from 98109
Shreveport, LA
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Novartis Investigative Site
Upland, California 91786
965
mi
from 98109
Upland, CA
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