The Mycophenolate Pregnancy Registry

Study type

• Study topic:
  Human medicinal product
• 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.
• Data collection methods:
  Primary data collection

Non-interventional study

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

Study drug and medical condition

• Medicinal product name:
  CELLCEPT

  MYFORTIC
• 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.; • Understand the circumstances that led to fetal exposure (pregnancy root cause analysis).; • Identify factors that affect the risk of adverse outcomes such as dose, timing of exposure, or maternal characteristics.
• Outcomes:
  • Overall pregnancy outcome (spontaneous losses/miscarriages, live births, fetal deaths, and elective terminations); • Any adverse fetal outcomes or birth defects that may be attributable to pregnancy exposure to mycophenolate; • Duration of mycophenolate exposure (peri-conception and by gestational period); • Mycophenolate product dose and regimen; • Indication for mycophenolate product use; • Maternal medical/demographic characteristics; • Root cause analysis: intended vs. unintended pregancies, contraception use, and education (occurrence of educational counseling on the risks of birth defects with mycophenolate therapy); • Gestational age at completion or termination of the pregnancy; • Pregnancy complications and fetal outcomes, including birth defects, birth weight and length and neurodevelopmental status; • In spontaneous losses, elective terminations and stillbirths, any birth defects identified prenatally or reported based on pathology reports
• Data analysis plan:
  All statistical 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 birth defect rate. For pregnancies with known outcome, line listings and descriptive summaries will be included.