A multicenter postmarketing study to evaluate the placental transfer of certolizumab pegol in pregnant women receiving treatment with Cimzia® (certolizumab pegol) (CRIB)

Study identification

• EU PAS number:
  EUPAS5507
• Study ID:
  21694
• Official title and acronym:
  A multicenter postmarketing study to evaluate the placental transfer of certolizumab pegol in pregnant women receiving treatment with Cimzia® (certolizumab pegol) (CRIB)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Netherlands

  Switzerland

  United States
• Study description:
  The primary purpose is to assess whether there is transfer of CZP from pregnant women receiving treatment with Cimzia® across the placenta to infants by evaluating the concentration of CZP in the plasma of infants at birth.
• Study status:
  Finalised

Research institutions and networks

Institutions

1 Chapel Hill, NC, USA, 20 Bern, Switzerland, 11 Scottsdale, AZ, USA, 7 & 3 Los Angeles, CA & Durham, NC, USA, 500 Maastricht, Netherlands, 9 Oklahoma City, OK, USA, 200 & 202 Paris, France, 203 Lille, France, 101 & 102 Salt Lake City, Utah & New York, NY, USA, 103 Houston, TX, USA

Study timelines

Date when funding contract was signed

Actual:12/09/2013

Study start date

Planned:14/01/2014

Actual:09/01/2014

Data analysis start date

Actual:21/11/2016

Date of final study report

Planned:21/11/2017

Actual:17/02/2017

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