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NCT02437162 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis
A Phase 3 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 3
- Development phase
- 347
- Enrollment target
NCT02437162: Clinical Trial Phase 3 study, sponsored by Janssen Research & Development.
NCT02437162 is a Phase 3 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 347 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02437162, a Phase 3 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 347 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.
Primary Outcome
ASAS 40 defined as improvement from baseline of greater than or equal to (\>=) 40 percent (%) and absolute improvement from baseline of at least 2 on 0 to 10 centimeter (cm) scale in at least 3 of following 4 domains: Patient's global assessment (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and
Interventions
- DRUG Placebo
- DRUG Ustekinumab 45 mg
- DRUG Ustekinumab 90 mg
- DRUG Golimumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 347 participants |
| Start Date | 2015-09-03 |
| Est. Completion | 2017-09-06 |
| Phase | Phase 3 |
Why NCT02437162 stopped before completion
NCT02437162 is an interventional study that assigns participants to a tested intervention. The registered 347 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 (55% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT02437162 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02437162 about?
NCT02437162 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of Ustekinumab in the Treatment of Anti-TNFα Naive Participants With Active Radiographic Axial Spondyloarthritis". The purpose of this study is to assess the efficacy of ustekinumab, in adult participants with active radiographic axial spondyloarthritis (AxSpA), who are naive to anti-TNF alpha agents, as measured by the reduction in signs and symptoms of radiographic AxSpA.
What is the current status of trial NCT02437162?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 347 participants. The study started on 2015-09-03. Estimated completion is 2017-09-06.
What interventions are being tested in trial NCT02437162?
The interventions under investigation include: Placebo (DRUG), Ustekinumab 45 mg (DRUG), Ustekinumab 90 mg (DRUG), Golimumab 50 mg (DRUG).
Who is sponsoring clinical trial NCT02437162?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02437162's enrollment target sits among peer trials
347 1048th of 2000 higher than 952 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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