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NCT04163016 · ClinicalTrials.gov registry record · Phase 1
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)
A Phase 1 study, sponsored by UCB Biopharma SRL.
- Completed
- Registry status
- Phase 1
- Development phase
- 22
- Enrollment target
NCT04163016: Completed Phase 1 study, sponsored by UCB Biopharma SRL.
NCT04163016 is a Phase 1 study that has completed, run by UCB Biopharma SRL. The registered enrollment target is 22 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04163016, a Phase 1 study, has completed, sponsored by UCB Biopharma SRL.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
Primary Outcome
Predose and postdose plasma CZP concentrations in women during pregnancy, relative to postpartum, were measured. The trimesters were defined as follows: Trimester 1=up to 12 weeks and 6 days gestation, trimester 2=13-28 weeks and 6 days gestation, and trimester 3=any time at or after 29 weeks gestation.
Interventions
- DRUG Pharmacokinetics of certolizumab pegol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2020-06-19 |
| Est. Completion | 2023-05-23 |
| Phase | Phase 1 |
What the finished NCT04163016 record still lists
NCT04163016 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (63% lower).
The record links to 0 conditions, and to 1 intervention - of which Pharmacokinetics of certolizumab pegol is the first listed.
NCT04163016 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04163016 about?
NCT04163016 is a clinical study titled "A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia (Certolizumab Pegol)". The purpose of the study is to assess systemic certolizumab pegol (CZP) exposure, the formation of anti-CZP antibodies and safety of CZP across the course of pregnancy in study participants with chronic inflammatory diseases.
What is the current status of trial NCT04163016?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 22 participants. The study started on 2020-06-19. Estimated completion is 2023-05-23.
What interventions are being tested in trial NCT04163016?
The interventions under investigation include: Pharmacokinetics of certolizumab pegol (DRUG).
Who is sponsoring clinical trial NCT04163016?
This trial is sponsored by UCB Biopharma SRL, which has 82 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04163016's enrollment target sits among peer trials
22 1601st of 2000 higher than 386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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