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NCT01087762 · ClinicalTrials.gov registry record · Phase 3
Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
A Phase 3 study, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 325
- Enrollment target
NCT01087762: Completed Phase 3 study, sponsored by UCB Biosciences.
NCT01087762 is a Phase 3 study that has completed, run by UCB Biosciences. The registered enrollment target is 325 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (58% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01087762, a Phase 3 study, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 325 participants
- Enrollment target
Study Summary
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Primary Outcome
The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: * Patient's Global Assessment of Disease Activity * Pain assessment (total spinal pain) * Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) * Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensit
Interventions
- OTHER Placebo
- BIOLOGICAL CZP 200 mg Q2W
- BIOLOGICAL CZP 400 mg Q4W
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2010-03 |
| Est. Completion | 2015-08 |
| Phase | Phase 3 |
What the finished NCT01087762 record still lists
NCT01087762 is an interventional study that assigns participants to a tested intervention. The registered 325 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 (58% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01087762 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01087762 about?
NCT01087762 is a clinical study titled "Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis". The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
What is the current status of trial NCT01087762?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 325 participants. The study started on 2010-03. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01087762?
The interventions under investigation include: Placebo (OTHER), CZP 200 mg Q2W (BIOLOGICAL), CZP 400 mg Q4W (BIOLOGICAL).
Who is sponsoring clinical trial NCT01087762?
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 NCT01087762's enrollment target sits among peer trials
325 1076th of 2000 higher than 922 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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