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Pregnancy and Lactation Studies

ENROLLING PREGNANCY AND LACTATION STUDIES

BELIMUMAB (BENLYSTA™) PREGNANCY REGISTRY

If you are pregnant and have been given belimumab (BENLYSTA) within the four months prior to becoming pregnant and/or during pregnancy, you are eligible to participate in this global registry. The pregnant woman or one of her health care providers may contact the registry at:

The CHERISH study

CHERISH is a clinical research study that will measure certolizumab pegol (Cimzia®) plasma levels in the blood over the course of pregnancy and after delivery.  By participating in the study, you may help provide new information that may benefit pregnant women who have an inflammatory disease in the future. The information learned from this study may lead toward a better understanding how Cimzia® works during pregnancy.

HEPLISAV-B® (Hepatitis B Vaccine [Recombinant], Adjuvanted) Pregnancy Registry

Pregnant women who have been vaccinated with HEPLISAV-B® (Hepatitis B Vaccine [Recombinant], Adjuvanted) within 28 days prior to conception or at any time during the pregnancy are eligible to participate in this U.S. registry. They may contact the registry at:

T.A.P.P. (Take Action to Prevent Pregnancy) Pregnancy Monitoring Program for Acitretin

If you think you’ve become pregnant while taking Acitretin or within three years of stopping, contact the program at:

CLOSED PREGNANCY AND LACTATION STUDIES

BEXSERO® Pregnancy Registry

An observational study of the use and safety of BEXSERO® in pregnant women and their offspring.
https://clinicaltrials.gov/ct2/show/NCT02640677?term=Bexsero+Pregnancy+Registry&rank=1

CRADLE

A multicenter postmarketing study to evaluate breast milk transfer in lactating mothers receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
https://clinicaltrials.gov/ct2/show/NCT02154425?term=CRADLE&rank=3

CRIB

A multicenter postmarketing study to evaluate placental transfer in women receiving treatment for rheumatoid arthritis, Crohn’s disease, psoriatic arthritis or ankylosing spondylitis.
https://clinicaltrials.gov/ct2/show/NCT02019602?term=CRIB&rank=4

MENVEO® Vaccine Pregnancy Registry

An observational study of the use and safety of MENVEO® in pregnant women and their offspring.
https://www.clinicaltrials.gov/ct2/show/NCT02223637?term=Menveo+pregnancy+registry&rank=1

Oseltamivir Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of oseltamivir exposure in pregnant women and their offspring.
Email address: Pregnancyand.InfantRegistriesSM@ppdi.com

Vedolizumab (Entyvio®) Lactation Study

A multicenter postmarketing study to evaluate breast milk transfer in women receiving vedolizumab (Entyvio®) for ulcerative colitis or Crohn’s disease.
https://www.clinicaltrials.gov/ct2/show/NCT02559713?term=Vedolizumab+%28Entyvio%C2%AE%29+Lactation+Study&rank=1

Xolair® Pregnancy Registry

An observational study of the use and safety of Xolair® (Omalizumab) during pregnancy (EXPECT).
https://clinicaltrials.gov/ct2/show/NCT00373061?term=EXPECT&rank=10

Zanamivir (Relenza inhalation powder) Safety in Pregnancy

European-based, retrospective, observational, database study assessing the safety of zanamivir (Relenza inhalation powder) exposure in pregnant women and their offspring.

Email address:
Pregnancyand.InfantRegistriesSM@ppdi.com