Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01649375 · ClinicalTrials.gov registry record · Phase 3
16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 219
- Enrollment target
NCT01649375: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01649375 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 219 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01649375, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 219 participants
- Enrollment target
Study Summary
This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
Primary Outcome
ASAS 20 response is a validated composite assessment reflecting the percentage of treated patients who achieve within a defined timeframe an improvement of 20% and ≥1 unit on a scale of 1 to 10 in at least three of the four ASAS main domains and no worsening of ≥20% and ≥1 unit in the remaining 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 | 219 participants |
| Start Date | 2012-10-18 |
| Est. Completion | 2018-09-18 |
| Phase | Phase 3 |
What the finished NCT01649375 record still lists
NCT01649375 is an interventional study that assigns participants to a tested intervention. The registered 219 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 (72% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01649375 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01649375 about?
NCT01649375 is a clinical study titled "16 Week Efficacy and 5 Year Long Term Efficacy, Safety and Tolerability of Secukinumab in Patients With Active Ankylosing Spondylitis". This study assessed the efficacy and safety of secukinumab in patients with active ankylosing spondylitis who were tolerant to or had an inadequate response to NSAIDs, DMARDs and / or TNFα inhibitor
What is the current status of trial NCT01649375?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 219 participants. The study started on 2012-10-18. Estimated completion is 2018-09-18.
What interventions are being tested in trial NCT01649375?
The interventions under investigation include: Placebo (DRUG), Secukinumab (75 mg) (DRUG), Secukinumab (150 mg) (DRUG).
Who is sponsoring clinical trial NCT01649375?
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 NCT01649375's enrollment target sits among peer trials
219 1329th of 2000 higher than 670 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05196035 · 219 participants · Phase 3
A Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria
- NCT05608434 · 219 participants · Phase 1
Development of Virtual Reality-based Interventions to Strengthen Cognitive Skillsets Related to Attention Deficit Hyperactivity Disorder (ADHD): A Pilot Phase I and Randomized Controlled Phase II Trial
- NCT05773144 · 219 participants · NA
Adaptive Randomization of Aerobic Exercise During Chemotherapy in Colon Cancer
- NCT05907980 · 219 participants · Phase 1
A Phase I Study of ROSE12 Alone and in Combination With Other Anti-tumor Agents in Patients With Solid Tumors
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI