The ZEPOSIA UC Pregnancy Registry

Why is the registry important?

The registry will help us learn more about the safety of using ZEPOSIA® (ozanimod) and other ulcerative colitis medications during pregnancy.

Who is eligible to participate?

Patients may be eligible if they are:

  • A resident of the United States or Canada
  • A pregnant woman diagnosed with ulcerative colitis who has either:
    • Taken ZEPOSIA® (ozanimod) during pregnancy or within 3 months prior to pregnancy OR
    • Taken other ulcerative colitis medications during pregnancy or just prior to pregnancy*

*Please note: If your patient has taken sphingosine-1-phosphate (S1P) medications (e.g., Gilenya®, Mayzent®, Ponvory™) or methotrexate during pregnancy or just prior to pregnancy (within a month of last menstrual period), they may not be eligible to participate. The registry staff can help determine patients’ eligibility if these medications have been taken.

What is ZEPOSIA® (ozanimod)?

ZEPOSIA® (ozanimod) is a prescription medicine made by Celgene Corporation, a Bristol-Myers Squibb Company, that is used for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).

How do I participate?

If you have patients who you think may be eligible, you can help them enroll by having them:

Complete the Contact Request Form here and a registry staff member will contact them

Email the registry team with their contact information at:

Call the registry team toll-free at
1-877-331-1166
(hours of operation 8.30am – 5.00 pm EST)

Why is this study needed?

Ulcerative colitis may be more prevalent among women compared to men and the incidence is highest during women’s childbearing years.1,2 Studies of pregnant patients with ulcerative colitis also suggest that there may be increased risk of low birthweight, preterm birth, spontaneous abortion, cesarean delivery, small for gestational age birth, and neonatal death associated with the disease.3,4,5 Since pregnant women are excluded from clinical trial participation, there is limited data on the potential impact of using ulcerative colitis medications during pregnancy on pregnancy and infant outcomes.

Eligible patients and their healthcare providers will provide information to the registry about their pregnancies and the health of their infants up to 1 year of age. This information can be provided by completing paper forms, via the free registry app, via the website portal or via a short phone interview with one of the registry staff members. Only information normally documented in patients’ medical records will be collected.

There will be:

  • No extra doctor’s visits or additional testing
  • No changes to patients’ medications or care

Their doctors will receive compensation for providing data to the registry.

The pregnant woman’s healthcare provider(s) will be asked to provide data at enrollment, approximately the end of the second trimester, and pregnancy outcome. For live-born infants, healthcare provider(s) will be asked to provide data at approximately 4 and 12 months after delivery.

The following data will be collected:

  • Maternal obstetrical history
  • Family history of congenital malformations
  • Ulcerative colitis history
  • Baseline and ongoing pregnancy information, including pregnancy data and prenatal test information
  • Maternal exposures during pregnancy
  • Maternal medical conditions and pregnancy complications
  • Pregnancy outcome information, including fetus/infant characteristics and presence of congenital malformations
  • Infant infections, illnesses, and hospitalizations
  • Infant growth and development information

Healthcare providers will be compensated each time they submit data to the registry.

Eligible patients will be asked to provide basic demographic information (e.g., race, ethnicity, education), height, and weight to the registry at enrollment.

Thank you for your support in recruiting potential participants.

References

  1. Shivashankar R, Tremaine WJ, Harmsen WS, et al. Incidence and prevalence of Crohn’s disease and ulcerative colitis in Olmsted County, Minnesota from 1970 through 2010. Clin Gastroenterol Hepatol 2017;15(6):857-63.
  2. Betteridge JD, Armbruster SP, Maydonovitch C, et al. Inflammatory bowel disease prevalence by age, gender, race, and geographic location in the U.S. military health care population. Inflamm Bowel Dis 2013;19(7):1421-7.
  3. Lin H-C, Chiu C-C, Chen S-F, et al. Ulcerative colitis and pregnancy outcomes in an Asian population. Am J Gastroenterol 2010;105(2):387-94.
  4. Puri A, Bharadwaj V, Sachdeva S. Extent of disease is a major outcome predictor in patients with ulcerative colitis and pregnancy. Indian J Gastroenterol 2015;34(2):108-11.
  5. Stephansson O, Larsson H, Pedersen L, et al. Congenital abnormalities and other birth outcomes in children born to women with ulcerative colitis in Denmark and Sweden. Inflamm Bowel Dis 2011;17(3):795-801.