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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:

Toll-free phone number (North America): +1 877 681 6296
Toll-free worldwide access fax number: +1 855 269 6182
Email address: belimumab.pregnancy@ppdi.com
Website: http://pregnancyregistry.gsk.com/belimumab.html

The BEXSERO® Pregnancy Registry

Pregnant women vaccinated with BEXSERO® within 30 days prior to the last menstrual period (LMP) or at any time during pregnancy and who are currently pregnant are eligible to participate in this U.S. registry. The pregnant woman or one of her health care providers may contact the registry at:

Toll-free phone number (US): +1 877 413 4759
Toll-free fax number (US): +1 866 898 0564
Email address: BEXSEROPregnancyRegistry.SM@ppdi.com
Website: http://pregnancyregistry.gsk.com/bexsero.html

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:

Toll-free phone number (US): +1 844 443 7734
Toll-free fax number (US): +1 877 202 3940
Email address: heplisavbpregnancyregistry@ppdi.com

MENVEO® Vaccine Pregnancy Registry

Pregnant women vaccinated with MENVEO® within 28 days prior to conception or at any time during pregnancy and who are currently pregnant are eligible to participate in this U.S. registry. The pregnant woman or one of her health care providers may contact the registry at:

Toll-free phone number (US): +1 877 413 4759
Toll-free fax number (US): +1 866 898 0564
Email address: MENVEOPregnancyRegistry.SM@ppdi.com
Website: http://pregnancyregistry.gsk.com/menveo.html

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:

Toll-free phone number (US): +1 855 850 2138
Toll-free fax number (US): +1 855 850 2137
Website: http://www.tevagenerics.com/acitretin

Vedolizumab (Entyvio®) Lactation Study

A clinical research study is looking for women age 18 years or older who are taking vedolizumab (Entyvio®) for ulcerative colitis or Crohn’s disease, and are currently breastfeeding a child. The woman or health care providers may contact the study team to learn more about this study:

Toll-free phone number (US): +1 877 212 7572
Email address: Vedo4001@ppdi.com
Website: www.UCandbreastfeeding.com

Closed Pregnancy and Lactation Studies

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

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

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

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