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NCT02505542 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 736
- Enrollment target
NCT02505542: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT02505542 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 736 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02505542, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 736 participants
- Enrollment target
Study Summary
Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
Primary Outcome
A participant was considered to have experienced a flare if the participant had an Ankylosing spondylitis disease activity score (ASDAS) greater or equal to (≥) 2.1 at 2 consecutive visits or an ASDAS greater than (\>) 3.5 at any visit during Part B up until Week 96. A participant qualified for Part B only if he achieved sustained remission after 48 weeks of Open-Label certolizumab pegol (CZP) treatment. Sustained remission was achieved when a participant had an ASDAS less than (\<) 1.3 at Week
Interventions
- OTHER Placebo
- BIOLOGICAL Certolizumab Pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 736 participants |
| Start Date | 2015-07 |
| Est. Completion | 2019-04 |
| Phase | Phase 3 |
What the finished NCT02505542 record still lists
NCT02505542 is an interventional study that assigns participants to a tested intervention. The registered 736 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02505542 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02505542 about?
NCT02505542 is a clinical study titled "Study to Evaluate Maintenance of Sustained Remission of axSpA With CZP Compared to Placebo". Patients receive study drug for one year (Part A). If, after the initial run-in phase, a sustained remission is reached they will be randomly split into one of three dose groups for another year (Part B). The maintenance of the sustained remission will be analyzed.
What is the current status of trial NCT02505542?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 736 participants. The study started on 2015-07. Estimated completion is 2019-04.
What interventions are being tested in trial NCT02505542?
The interventions under investigation include: Placebo (OTHER), Certolizumab Pegol (BIOLOGICAL).
Who is sponsoring clinical trial NCT02505542?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02505542's enrollment target sits among peer trials
736 479th of 2000 higher than 1,520 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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