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NCT01431638 · ClinicalTrials.gov registry record · Phase 3
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 397
- Enrollment target
NCT01431638: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01431638 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 397 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01431638, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 397 participants
- Enrollment target
Study Summary
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
Interventions
- DRUG Canakinumab 150mg in prefilled syringe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 397 participants |
| Start Date | 2011-08-25 |
| Est. Completion | 2013-05-09 |
| Phase | Phase 3 |
What the finished NCT01431638 record still lists
NCT01431638 is an interventional study that assigns participants to a tested intervention. The registered 397 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 (49% lower).
The record links to 0 conditions, and to 1 intervention - of which Canakinumab 150mg in prefilled syringe is the first listed.
NCT01431638 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01431638 about?
NCT01431638 is a clinical study titled "Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients". This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
What is the current status of trial NCT01431638?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 397 participants. The study started on 2011-08-25. Estimated completion is 2013-05-09.
What interventions are being tested in trial NCT01431638?
The interventions under investigation include: Canakinumab 150mg in prefilled syringe (DRUG).
Who is sponsoring clinical trial NCT01431638?
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 NCT01431638's enrollment target sits among peer trials
397 964th of 2000 higher than 1,037 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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