Status:
COMPLETED
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to demonstrate the impact of secukinumab on the progression of structural damage in the spine, as measured by the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS...
Detailed Description
This was a Phase IIIb, multi-center, randomized, partially-blinded, active-controlled, parallel-group design in subjects with AS. The study consisted of a screening period (up to 10 weeks before rando...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 30 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 29 2021
Estimated Enrollment :
859 Patients enrolled
Trial Details
Trial ID
NCT03259074
Start Date
November 30 2017
End Date
November 29 2021
Last Update
August 21 2023
Active Locations (171)
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1
Novartis Investigative Site
Mesa, Arizona, United States, 85202
2
Novartis Investigative Site
Escondido, California, United States, 92025
3
Novartis Investigative Site
La Mesa, California, United States, 91942
4
Novartis Investigative Site
San Francisco, California, United States, 94143 0138