Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)



Status:Recruiting
Conditions:Arthritis, Neurology, Neurology
Therapuetic Areas:Neurology, Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:July 10, 2017
End Date:January 20, 2022
Contact:Novartis Pharmaceuticals
Email:novartis.email@novartis.com
Phone:1-888-669-6682

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A Randomized, Partially-blinded Study of Secukinumab to Demonstrate Reduction of Radiographic Progression Versus GP2017 (Adalimumab Biosimilar) at 104 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Ankylosing Spondylitis

The purpose of this study is to demonstrate the impact of secukinumab on progression of
structural damage in the spine, as measured by the mSASSS in patients with AS.


Inclusion Criteria:

- Male or non-pregnant, non-nursing female patients at least 18 years of age

- Diagnosis of moderate to severe Ankylosing Spondylitis with radiologic evidence
(centrally read X-ray) fulfilling the Modified New York criteria for AS despite
previous or current NSAID/ nonbiologic DMARD therapy

- Active AS assessed by total BASDAI ≥ 4 on a scale of 0-10

- Spinal pain as measured by BASDAI question #2 ≥ 4 (0-10)

- Total back pain as measured by visual analog scale (VAS) ≥ 40 mm (0-100 mm)

- hsCRP ≥ 5 mg/L OR presence of at least 1 syndesmophyte on centrally read spinal X-ray

Exclusion Criteria:

- Patients with total ankylosis of the spine

- Pregnant or nursing (lactating) women

- Evidence of ongoing infectious or malignant process

- Previous exposure to any biologic immunomodulating agent, including those targeting
IL-17, IL-17 receptor or TNFα

- Subjects taking high potency opioid analgesics

- Previous treatment with any cell-depleting therapies including but not limited to
anti-CD20, investigational agents

Other protocol-defined inclusion/exclusion criteria may apply
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Lincoln, Nebraska 68506
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Atlanta, Georgia 30322
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Boston, Massachusetts 02118
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Brooklyn, New York 11218
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Carrollton, Texas 75010
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Cutler Bay, Florida 33157
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Duncansville, Pennsylvania 16635
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Eagan, Minnesota 55121
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Escondido, California 92025
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Franklin, Wisconsin 53132
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Great Falls, Montana 59405
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Greensboro, North Carolina 27401
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Greenwood Village, Colorado 80111
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Hagerstown, Maryland 21742
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Idaho Falls, Idaho 83404
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Jackson Heights, New York 11372
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Kennewick, Washington 99336
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La Mesa, California 91942
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Malvern East, Victoria
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Memphis, Tennessee 38120
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Mesquite, Texas 75150
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Middleburg Heights, Ohio 44130
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Nashville, Tennessee 37205
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Paradise Valley, Arizona 85253
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Peoria, Illinois 61615
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Perrysburg, Ohio 43551
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1 Health Plaza
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Stamford, Connecticut 06905
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Tampa, Florida 33613
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Trumbull, Connecticut 06611
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Wheaton, Maryland 20902
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Yonkers, New York 10701
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