An observational follow-up study of women who become pregnant while participating in a certolizumab pegol (CZP) clinical study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy

Study identification

• EU PAS number:
  EUPAS11321
• Study ID:
  27134
• Official title and acronym:
  An observational follow-up study of women who become pregnant while participating in a certolizumab pegol (CZP) clinical study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Germany

  United States
• Study description:
  The purpose of this observational follow-up study is to collect data systematically on pregnancies and offspring in women who become pregnant while participating in a CZP clinical study or whose pregnancies have otherwise been reported to UCB due to potential CZP exposure during pregnancy.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 4 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned:11/12/2015

Actual:11/12/2015

Study start date

Planned:30/12/2016

Actual:16/11/2016

Date of final study report

Planned:18/12/2018

Actual:18/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

UCB BIOSCIENCES, Inc.

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable