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

Trial Profile

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

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 25 Mar 2019

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At a glance

  • Drugs Certolizumab pegol (Primary)
  • Indications Ankylosing spondylitis; Crohn's disease; Psoriatic arthritis; Rheumatoid arthritis; Spondylitis
  • Focus Adverse reactions; Pharmacokinetics
  • Acronyms CRADLE
  • Sponsors UCB
  • Most Recent Events

    • 25 Mar 2019 According to a UCB media release, the Health Canada has approved label updates in pregnancy and breastfeeding based on two pivotal pharmacokinetic studies (CRIB and CRADLE).
    • 22 Mar 2018 Results published in UCB the Media Release
    • 22 Mar 2018 According to an UCB media release, The approval of the CIMZIA label update is based on data from the post-marketing pharmacokinetic CRIB and CRADLE studies
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