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NCT00308581 · ClinicalTrials.gov registry record · Phase 3
Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab
A Phase 3 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 539
- Enrollment target
NCT00308581: Completed Phase 3 study, sponsored by UCB Pharma.
NCT00308581 is a Phase 3 study that has completed, run by UCB Pharma. The registered enrollment target is 539 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00308581, a Phase 3 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 539 participants
- Enrollment target
Study Summary
To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
Primary Outcome
Response is defined as at least 100 point decrease in Crohn's Disease Activity Score (CDAI score) from baseline, otherwise there is a non-response. The CDAI score is used to quantify the symptoms of subjects with Crohn's Disease. A score of 150 or below indicates remission and a score above 450 indicates extremely severe disease. A decrease in CDAI over time indicates improvement in disease activity.
Interventions
- OTHER Placebo
- BIOLOGICAL Certolizumab pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 539 participants |
| Start Date | 2006-04 |
| Est. Completion | 2008-04 |
| Phase | Phase 3 |
What the finished NCT00308581 record still lists
NCT00308581 is an interventional study that assigns participants to a tested intervention. The registered 539 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 (30% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00308581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00308581 about?
NCT00308581 is a clinical study titled "Certolizumab in Crohn's Disease Patients With Loss of Response or Intolerance to Infliximab". To assess the clinical efficacy of subcutaneous (sc) certolizumab pegol administration over 26 weeks in patients suffering from Crohn's Disease (CD) and previously treated with infliximab
What is the current status of trial NCT00308581?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 539 participants. The study started on 2006-04. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00308581?
The interventions under investigation include: Placebo (OTHER), Certolizumab pegol (BIOLOGICAL).
Who is sponsoring clinical trial NCT00308581?
This trial is sponsored by UCB Pharma, which has 100 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00308581's enrollment target sits among peer trials
539 700th of 2000 higher than 1,301 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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