The Mycophenolate Pregnancy Registry

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Voluntary reporting by HCPs and/or patients of any mycophenolate-exposed pregnancy in the US.

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  A prospective, observational registry

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MYCOPHENOLATE MOFETIL

  MYCOPHENOLIC ACID
• Medical condition to be studied:
  Pregnancy

Population studied

• Age groups:
  Preterm newborn infants (0 – 27 days)

  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Special population of interest:
  Pregnant women
• Estimated number of subjects:
  500

Study design details

• Main study objective:
  • Document maternal and fetal outcomes of each exposed pregnancy to further characterize the risk of mycophenolate fetal exposure. • Determine mycophenolate exposure status for each reported pregnancy.• Root cause analysis of circumstances that led to fetal exposure.• Identify factors that affect the risk of adverse outcomes such as dose, timing of exposure, or maternal characteristics.
• Outcomes:
  • Maternal outcomes: Incidence of pregnancy complications• Fetal outcomes: Incidence of congenital disorders• Time/duration of mycophenolate exposure• Mycophenolate dose/regimen• Indications for mycophenolate use• Maternal medical/demographic characteristics, • Occurrence of educational counseling on the risks of birth defects with mycophenolate therapy
• Data analysis plan:
  All statistical analyses will be coordinated by Outcome Sciences, Inc. Analyses and reporting will be performed semi-annually, for regulatory update or other purposes, and possibly more often according to the needs of and at the discretion of the Registry sponsor(s) and the Mycophenolate Pregnancy. Based on the prospective case data, 95% confidence intervals will be constructed around the observed defect rate. For pregnancies with known outcome, line listings and descriptive summaries will be included.