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 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.
- Toll-free phone number (U.S.): +1 877 302 2822
- Email address: CHERISH.sm@ppdi.com
- Website: https://thecherishstudy.com/us/en/screener
- Clinicaltrials.gov: https://clinicaltrials.gov/ct2/show/NCT04163016?term=UP0085&draw=2&rank=1
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 (U.S.): +1 844 443 7734
- Toll-free fax number (U.S.): +1 877 202 3940
- Email address: heplisavbpregnancyregistry@ppdi.com
- Website: https://heplisavbpregnancyregistry.com
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 (U.S.): +1 855 850 2138
- Toll-free fax number (U.S.): +1 855 850 2137
- Website: http://www.tevagenerics.com/acitretin
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