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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:

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