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NCT01190410 · ClinicalTrials.gov registry record · Phase 2
Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol
A Phase 2 study, sponsored by UCB Pharma.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01190410: Completed Phase 2 study, sponsored by UCB Pharma.
NCT01190410 is a Phase 2 study that has completed, run by UCB Pharma. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01190410, a Phase 2 study, has completed, sponsored by UCB Pharma.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatment in children and adolescents with moderately to severely active Crohn's disease.
Primary Outcome
Treatment-Emergent Adverse Events (TEAEs) are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment.
Interventions
- DRUG certolizumab pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2010-08 |
| Est. Completion | 2017-11-27 |
| Phase | Phase 2 |
What the finished NCT01190410 record still lists
NCT01190410 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which certolizumab pegol is the first listed.
NCT01190410 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01190410 about?
NCT01190410 is a clinical study titled "Extension Study to Assess Long Term Safety in Children and Adolescents With Crohn's Disease Receiving Certolizumab Pegol". The purpose of this study is to evaluate the long-term safety and tolerability of certolizumab pegol (CZP) treatment in children and adolescents with moderately to severely active Crohn's disease. Secondarily, to assess the long-term efficacy, pharmacokinetics (PK), and immunogenicity of CZP treatme...
What is the current status of trial NCT01190410?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2010-08. Estimated completion is 2017-11-27.
What interventions are being tested in trial NCT01190410?
The interventions under investigation include: certolizumab pegol (DRUG).
Who is sponsoring clinical trial NCT01190410?
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 NCT01190410's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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