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NCT01358175 · ClinicalTrials.gov registry record · Phase 3
16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 371
- Enrollment target
NCT01358175: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01358175 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 371 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01358175, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 371 participants
- Enrollment target
Study Summary
This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
Primary Outcome
ASAS 20 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20% improvement in score in at least 3 of a conventional set of 4 clinical domains relevent to AS and no worsening in the fourth domain. ASAS 20 is used to assess the efficacy of at least one dose of secukinumab against placebo.
Interventions
- DRUG Placebo
- DRUG Secukinumab (75 mg)
- DRUG Secukinumab (150 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 371 participants |
| Start Date | 2011-10 |
| Est. Completion | 2014-12 |
| Phase | Phase 3 |
What the finished NCT01358175 record still lists
NCT01358175 is an interventional study that assigns participants to a tested intervention. The registered 371 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 (52% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01358175 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01358175 about?
NCT01358175 is a clinical study titled "16 Week Efficacy and 2 Year Long Term Safety and Efficacy of Secukinumab in Patients With Active Ankylosing Spondylitis". This study will assess the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor therapy.
What is the current status of trial NCT01358175?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 371 participants. The study started on 2011-10. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01358175?
The interventions under investigation include: Placebo (DRUG), Secukinumab (75 mg) (DRUG), Secukinumab (150 mg) (DRUG).
Who is sponsoring clinical trial NCT01358175?
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 NCT01358175's enrollment target sits among peer trials
371 992nd of 2000 higher than 1,008 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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