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A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers — CRADLE  

Rheumatoid Arthritis Clinical Trial

Official title:
A Multicenter, Postmarketing Study to Evaluate the Concentration of Certolizumab Pegol in the Breast Milk of Mothers Receiving Treatment With Cimzia® (Certolizumab Pegol)

Clinical Trial 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.

Clinical Trial Description

The study will only include women who are receiving treatment with Certolizumab Pegol (CZP) for an approved indication in accordance with their treating physician, although this study is non-interventional regarding treatment with CZP, it is considered interventional due to the collection of breast milk from the lactating mothers. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02154425
Study type Interventional
Source UCB Pharma
Contact
Status Completed
Phase Phase 1
Start date September 2014
Completion date January 2016
View Details
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