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NCT01863732 · ClinicalTrials.gov registry record · Phase 3
Extension in AS: Sustainability of Benefits, Safety and Tolerability
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
NCT01863732: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01863732 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01863732, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
Study Summary
This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical benefits, safety and tolerability during long-term administration of secukinumab.
Primary Outcome
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined time frame at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevant to AS and no worsening in the fourth domain. In this study, ASAS 20 is used to assess quantitatively the sustainability of clinical benefits of two dosage regimens of secukinumab over the treatment period from Week 104 to Week 260 No Statistical Analysis was
Interventions
- BIOLOGICAL Secukinumab
- OTHER Placebo (Pbo)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2013-11-06 |
| Est. Completion | 2018-03-16 |
| Phase | Phase 3 |
What the finished NCT01863732 record still lists
NCT01863732 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Secukinumab is the first listed.
NCT01863732 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01863732 about?
NCT01863732 is a clinical study titled "Extension in AS: Sustainability of Benefits, Safety and Tolerability". This 3-year extension study aims at making available the treatment with secukinumab in prefilled syringes (PFS) to patients with ankylosing spondylitis who took part in phase III study CAIN457F2305, defined as "core study", as well as to generate additional data on the sustainability of clinical ben...
What is the current status of trial NCT01863732?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2013-11-06. Estimated completion is 2018-03-16.
What interventions are being tested in trial NCT01863732?
The interventions under investigation include: Secukinumab (BIOLOGICAL), Placebo (Pbo) (OTHER).
Who is sponsoring clinical trial NCT01863732?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01863732's enrollment target sits among peer trials
274 1207th of 2000 higher than 788 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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