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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Wheaton, Maryland 20902
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Atlanta, Georgia 30322
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Carrollton, Texas 75010
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Duncansville, Pennsylvania 16635
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Kennewick, Washington 99336
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