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NCT02154425 · ClinicalTrials.gov registry record · Phase 1
A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers
A Phase 1 study of Rheumatoid Arthritis and Crohn's Disease, sponsored by UCB Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 17
- Enrollment target
- 6
- Study locations
NCT02154425: Completed Phase 1 study of Rheumatoid Arthritis and Crohn's Disease, sponsored by UCB Biosciences.
NCT02154425 is a Phase 1 study of Rheumatoid Arthritis and Crohn's Disease that has completed, run by UCB Biosciences. The registered enrollment target is 17 participants, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02154425, a Phase 1 study of Rheumatoid Arthritis and Crohn's Disease, has completed, sponsored by UCB Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 17 participants
- Enrollment target
- 6
- Study locations
Study Summary
The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose of maternal CZP.
Primary Outcome
Mature breast milk samples were collected predose on Day 0 of the Sampling Period (CZP dosing day) for all subjects.
Conditions Studied
Interventions
- PROCEDURE Breast milk sampling
- BIOLOGICAL Certolizumab Pegol
Study Locations (6)
Other
- 500 - Maastricht
- 501 - Rotterdam
- 20 - Bern
North Carolina
- 1 - Chapel Hill
- 3 - Durham
California
- 7 - Los Angeles
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2014-09 |
| Est. Completion | 2016-01 |
| Phase | Phase 1 |
What the finished NCT02154425 record still lists
NCT02154425 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 4,691-participant average among 197 other Rheumatoid Arthritis trials with a reported enrollment target (100% lower).
The record links to 6 conditions, with Rheumatoid Arthritis appearing as the primary indexed condition, and to 2 interventions - of which Breast milk sampling is the first listed.
NCT02154425 lists 6 locations in 3 states (Other, North Carolina, California).
Frequently Asked Questions
What is clinical trial NCT02154425 about?
NCT02154425 is a clinical study titled "A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers". The primary objectives of this study are to assess whether there is transfer of Certolizumab Pegol (CZP) into breast milk of lactating mothers who are receiving an established dosing regimen of CZP by evaluating the concentration of CZP in mature breast milk, and to calculate the daily infant dose o...
What is the current status of trial NCT02154425?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 17 participants. The study started on 2014-09. Estimated completion is 2016-01.
What conditions does trial NCT02154425 study?
This clinical trial studies the following conditions: Rheumatoid Arthritis, Crohn's Disease, Psoriatic Arthritis, Ankylosing Spondylitis, Axial Spondyloarthritis (AxSpA).
What interventions are being tested in trial NCT02154425?
The interventions under investigation include: Breast milk sampling (PROCEDURE), Certolizumab Pegol (BIOLOGICAL).
Who is sponsoring clinical trial NCT02154425?
This trial is sponsored by UCB Biosciences, which has 39 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02154425 being conducted?
This trial has 6 study locations across California, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02154425's enrollment target sits among peer trials
17 185th of 197 higher than 13 of 197 other Rheumatoid Arthritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rheumatoid Arthritis 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.
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