Efficacy at 24 Weeks With Long Term Safety, Tolerability and Efficacy up to 5 Years of Secukinumab in Patients of Active Psoriatic Arthritis



Status:Active, not recruiting
Conditions:Arthritis, Psoriasis
Therapuetic Areas:Dermatology / Plastic Surgery, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:April 14, 2013
End Date:January 14, 2019

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A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Prefilled Syringes to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Efficacy, Safety and Tolerability up to 5 Years in Patients With Active Psoriatic Arthritis

This study is to provide 24 - 52 week efficacy, safety and tolerability data to support the
registration of the secukinumab (AIN457) prefilled syringe (PFS) for subcutaneous self
administration in subjects with active PsA despite current or previous NSAID, DMARD and/or
anti-TNFα therapy. An additional 4 years of long-term efficacy and safety data will be
collected during the post Week 52 period of the study.


Inclusion Criteria:Patients eligible for inclusion in this study have to fulfill all of the
following criteria:

- 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 at screening

- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis or
documented history of plaque psoriasis

- Subjects with PsA should have taken NSAIDs for at least 4 weeks prior to randomization
with inadequate control of symptoms or at least one dose if stopped due to intolerance
to NSAIDs

- Subjects taking corticosteroids must be on a stable dose of ≤10 mg/day prednisone or
equivalent for at least 2 weeks before randomization and should remain on a stable
dose up to Week 24

- Subjects taking MTX (≤ 25 mg/week) are allowed to continue their medication if the
dose is stable for at least 4 weeks before randomization and should remain on a stable
dose up to Week 52.

Exclusion Criteria:Patients fulfilling any of the following criteria are not eligible for
inclusion in this study:

- Chest X-ray or chest MRI with evidence of ongoing infectious or malignant process,
obtained within 3 months prior to screening and evaluated by a qualified physician

- Subjects taking high potency opioid analgesics (e.g. methadone, hydromorphone,
morphine)

- Previous exposure to secukinumab or other biologic drug directly targeting IL-17 or
IL-17 receptor

- Ongoing use of prohibited psoriasis treatments / medications (e.g., topical
corticosteroids, UV therapy) at randomization. The following wash out periods need to
be observed:

- Oral or topical retinoids 4 weeks

- Photochemotherapy (e.g. PUVA) 4 weeks

- Phototherapy (UVA or UVB) 2 weeks

- Topical skin treatments (except in face, scalp and genital area during screening, only
corticosteroids with mild to moderate potency) 2 weeks

- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFα, investigational or approved

- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents (e.g., CAMPATH, anti-CD4, anti-CD5, anti-CD3,
anti-CD19)
We found this trial at
21
sites
Charleston, South Carolina 29407
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Charleston, SC
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Asheville, North Carolina 28803
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Asheville, NC
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Aventura, Florida 33180
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Aventura, FL
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Charlotte, North Carolina 28277
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Charlotte, NC
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Columbia, South Carolina 29201
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Columbia, SC
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Duncansville, Pennsylvania 16635
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Duncansville, PA
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Freehold, New Jersey 07728
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Freehold, NJ
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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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League City, Texas 77573
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League City, TX
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Lincoln, Nebraska 68506
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Lincoln, NE
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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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Omaha, Nebraska 68144
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Omaha, NE
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Palm Harbor, Florida 34684
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Palm Harbor, FL
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Peoria, Arizona 85381
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Peoria, AZ
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Sarasota, Florida 34239
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Sarasota, FL
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Syracuse, New York 13210
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Syracuse, NY
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Tamarac, Florida 33321
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Tamarac, FL
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Tampa, Florida 33613
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Tampa, FL
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Zephyrhills, Florida 33542
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Zephyrhills, FL
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