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
We found this trial at
39
sites
Trumbull, Connecticut 06611
522
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Trumbull, CT
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Atlanta, Georgia 30322
432
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Atlanta, GA
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Baton Rouge, Louisiana 70808
802
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Baton Rouge, LA
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Boise, Idaho 83712
1715
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Boise, ID
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Boston, Massachusetts 02118
643
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Boston, MA
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Brooklyn, New York 11218
478
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Brooklyn, NY
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Carrollton, Texas 75010
907
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Carrollton, TX
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Cutler Bay, Florida 33157
?
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Cutler Bay, FL
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Duncansville, Pennsylvania 16635
244
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Duncansville, PA
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Eagan, Minnesota 55121
616
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Eagan, MN
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Escondido, California 92025
1935
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Escondido, CA
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Franklin, Wisconsin 53132
?
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Franklin, WI
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Gainesville, Florida 32608
716
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Gainesville, FL
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Great Falls, Montana 59405
1493
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Great Falls, MT
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Greensboro, North Carolina 27401
322
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Greensboro, NC
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Greenwood Village, Colorado 80111
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Greenwood Village, CO
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Hagerstown, Maryland 21742
282
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Hagerstown, MD
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Idaho Falls, Idaho 83404
1507
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Idaho Falls, ID
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Jackson Heights, New York 11372
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Jackson Heights, NY
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Kennewick, Washington 99336
1856
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Kennewick, WA
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La Mesa, California 91942
1942
mi
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La Mesa, CA
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Lincoln, Nebraska 68506
718
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Lincoln, NE
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Malvern East, Victoria
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Memphis, Tennessee 38120
501
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Memphis, TN
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Mesa, Arizona 85205
1644
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Mesa, AZ
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Mesquite, Texas 75150
901
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Mesquite, TX
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Middleburg Heights, Ohio 44130
115
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Middleburg Heights, OH
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Nashville, Tennessee 37205
339
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Nashville, TN
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Paradise Valley, Arizona 85253
1653
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Paradise Valley, AZ
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Peoria, Illinois 61615
352
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Peoria, IL
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Perrysburg, Ohio 43551
114
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Perrysburg, OH
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San Francisco, California 94121
2111
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San Francisco, CA
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Seattle, Washington 98103
2007
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Seattle, WA
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Shreveport, Louisiana 71101
787
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Shreveport, LA
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1 Health Plaza
Somerset, New Jersey 08873
457
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Somerset, NJ
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Stamford, Connecticut 06905
503
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Stamford, CT
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Tampa, Florida 33613
821
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Tampa, FL
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Wheaton, Maryland 20902
325
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Wheaton, MD
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Yonkers, New York 10701
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Yonkers, NY
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