Ignite Creation Date:
2024-05-06 @ 1:56 PM
Last Modification Date:
2024-10-26 @ 1:22 PM
Study NCT ID:
NCT04163016
Status:
COMPLETED
Last Update Posted:
2023-06-18
First Post:
2019-10-24
Brief Title:
A Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia Certolizumab Pegol
Sponsor:
UCB Biopharma SRL
Organization:
UCB Pharma
Study Overview
Official Title:
A Postmarketing Multicenter Longitudinal Prospective Pharmacokinetic Phase 1B Study in Pregnant Women With Chronic Inflammatory Diseases Treated With Cimzia Certolizumab Pegol
Status:
COMPLETED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHERISH
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None