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NCT03259074 · ClinicalTrials.gov registry record · Phase 3
Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)
A Phase 3 study of Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 859
- Enrollment target
- 20
- Study locations
NCT03259074: Completed Phase 3 study of Ankylosing Spondylitis, sponsored by Novartis Pharmaceuticals.
NCT03259074 is a Phase 3 study of Ankylosing Spondylitis that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 859 participants, below the 38,140-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (98% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03259074, a Phase 3 study of Ankylosing Spondylitis, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 859 participants
- Enrollment target
- 20
- Study locations
Study 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) in patients with Ankylosing Spondylitis (AS).
Primary Outcome
Radiographic progression was based on scores from the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). The mSASSS is the sum of scores assessing the vertebral corners of the lumbar and cervical spine as 0 (normal), 1 (erosion, sclerosis, or squaring), 2 (syndesmophyte), or 3 (bridging syndesmophyte) with a total range from 0-72. No radiographic progression was defined as the change from baseline in mSASSS score \<= 0.5.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL GP2017 (adalimumab biosimilar)
- BIOLOGICAL AIN457 150 mg
Study Locations (20)
California
- Novartis Investigative Site - Escondido
- Novartis Investigative Site - La Mesa
- Novartis Investigative Site - San Francisco
Ohio
- Novartis Investigative Site - Dayton
- Novartis Investigative Site - Middleburg Heights
Arizona
- Novartis Investigative Site - Mesa
Florida
- Novartis Investigative Site - Gainesville
Idaho
- Novartis Investigative Site - Boise
Louisiana
- Novartis Investigative Site - Shreveport
Maryland
- Novartis Investigative Site - Wheaton
Montana
- Novartis Investigative Site - Great Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 859 participants |
| Start Date | 2017-11-30 |
| Est. Completion | 2021-11-29 |
| Phase | Phase 3 |
What the finished NCT03259074 record still lists
NCT03259074 is an interventional study that assigns participants to a tested intervention. The registered 859 participants enrollment target is mid-sized for trials with a published cap, below the 38,140-participant average among 15 other Ankylosing Spondylitis trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Ankylosing Spondylitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT03259074 names 20 study sites across 17 states, led by California, Ohio, Arizona.
Frequently Asked Questions
What is clinical trial NCT03259074 about?
NCT03259074 is a clinical study titled "Effect of Secukinumab on Radiographic Progression in Ankylosing Spondylitis as Compared to GP2017 (Adalimumab Biosimilar)". 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) in patients with Ankylosing Spondylitis (AS).
What is the current status of trial NCT03259074?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 859 participants. The study started on 2017-11-30. Estimated completion is 2021-11-29.
What conditions does trial NCT03259074 study?
This clinical trial studies the following conditions: Ankylosing Spondylitis.
What interventions are being tested in trial NCT03259074?
The interventions under investigation include: Placebo (BIOLOGICAL), GP2017 (adalimumab biosimilar) (BIOLOGICAL), AIN457 150 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT03259074?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03259074 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Idaho, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03259074's enrollment target sits among peer trials
859 7th of 15 higher than 9 of 15 other Ankylosing Spondylitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ankylosing Spondylitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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