Cimzia (Certolizumab Pegol) Pregnancy Exposure Registry: OTIS Autoimmune Diseases in Pregnancy Project
The Cimzia Pregnancy Exposure Registry is following pregnant women who have been treated with Cimzia during pregnancy and comparing them to pregnant women who were not exposed to Cimzia. Both groups of women and their babies will be followed up to 1 year after delivery. The goal is to determine the possible effect of Cimzia and the diseases it treats on pregnancy and infant outcomes.
- You must enroll before you are 20 weeks along in your pregnancy
- Any exposure to Cimzia must have occurred between your last menstrual period up to 13 weeks in your pregnancy
MotherToBaby is currently enrolling people who are less than 20 weeks pregnant who took Cimzia® (certolizumab pegol) to treat Crohn’s disease, rheumatoid arthritis, psoriasis, psoriatic arthritis, and/or ankylosing spondylitis during the 1st trimester of their current pregnancy. Participants complete 1-3 phone interviews during pregnancy and at least 1 interview after delivery. They are also asked to release the medical records for their pregnancy and for their baby so we can capture information about their health as the pregnancy progresses and the health of their baby after delivery.
Description of treatment or intervention (mechanism of action):
There is no treatment or intervention; this study is observational. We will not ask you to take a medication or to change any aspect of your current health routine.
Patient Participation Requirements:
• 1-3 phone interviews during your pregnancy and at least 1 interview after you have your baby.
• Your permission to obtain a copy of your and your baby’s medical records from your healthcare providers.
• An opportunity to receive a specialized, non-invasive exam of your baby with a study doctor
Possible risks and side effects:
You may feel uncomfortable or anxious answering questions about your pregnancy. You can skip or refuse any question, or end the interview at any time. There is a small chance that your information for this study may be mistakenly released to someone outside the study. We will protect your confidentiality by securely storing your information physically and electronically.