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NCT02296424 · ClinicalTrials.gov registry record · Phase 3
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 182
- Enrollment target
NCT02296424: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT02296424 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 182 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02296424, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 182 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
Primary Outcome
The primary efficacy variable for Part II was the proportion of patients in clinical remission on canakinumab 4 mg/kg (+/- concomitant NSAID only) who were able to remain on a reduced dose or on prolonged dose interval for at least 24 consecutive weeks. As the primary objective was to show statistically significance in at least one of canakinumab treatment arms (reduced dose and prolonged dose interval arms) in Part II then the Type I error rate 5% was controlled and split to 2.5%. Clinical remi
Interventions
- DRUG ACZ885 150 mg (Canakinumab)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2014-11-17 |
| Est. Completion | 2017-09-25 |
| Phase | Phase 3 |
What the finished NCT02296424 record still lists
NCT02296424 is an interventional study that assigns participants to a tested intervention. The registered 182 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 (76% lower).
The record links to 0 conditions, and to 1 intervention - of which ACZ885 150 mg (Canakinumab) is the first listed.
NCT02296424 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02296424 about?
NCT02296424 is a clinical study titled "ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab". The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
What is the current status of trial NCT02296424?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 182 participants. The study started on 2014-11-17. Estimated completion is 2017-09-25.
What interventions are being tested in trial NCT02296424?
The interventions under investigation include: ACZ885 150 mg (Canakinumab) (DRUG).
Who is sponsoring clinical trial NCT02296424?
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 NCT02296424's enrollment target sits among peer trials
182 1421st of 2000 higher than 579 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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