A multicenter, postmarketing study to evaluate the concentration of certolizumab pegol in the breast milk of mothers receiving treatment with Cimzia® (certolizumab pegol) (CRADLE)

Study identification

• EU PAS number:
  EUPAS6785
• Study ID:
  16581
• Official title and acronym:
  A multicenter, postmarketing study to evaluate the concentration of certolizumab pegol in the breast milk of mothers receiving treatment with Cimzia® (certolizumab pegol) (CRADLE)
• DARWIN EU® study:
  No
• Study countries:
  Canada

  France

  Netherlands

  Switzerland

  United States
• Study description:
  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.
• Study status:
  Finalised

Research institutions and networks

Institutions

Multiple centres: 15 centres are involved in the study
11, Scottsdale, AZ, USA
7, Los Angeles, CA, USA
1, Chapel Hill, NC, USA
3, Durham, NC, USA
101, Salt Lake City, UT, USA
500 & 501, Maastricht & Rotterdam, Netherlands
20, Bern, Switzerland
102, New York, NY, USA
200, Paris, France
103, Houston, TX, USA

Study timelines

Date when funding contract was signed

Actual:19/12/2013

Study start date

Planned:26/06/2014

Actual:08/09/2014

Data analysis start date

Planned:22/11/2016

Date of final study report

Planned:10/01/2017

Actual:17/05/2016

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