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: 01 Apr 2019
Price :
$35
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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
- 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