Registry for monitoring pregnancy outcomes after mycophenolate exposure
The Mycophenolate Pregnancy Registry
This study is collecting information on pregnancy outcomes for women who took mycophenolate during pregnancy to see how it affects both mothers and babies.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Sex | Female |
| Sponsor | Genentech, Inc. Industry-sponsored |
| Locations | 1 site (Cambridge, Massachusetts) |
| Trial ID | NCT01733082 on ClinicalTrials.gov |
What this trial studies
The Mycophenolate Pregnancy Registry is an observational registry that collects data on pregnancy outcomes for women exposed to mycophenolate during pregnancy. It aims to gather information on both maternal and fetal outcomes, including any structural or functional birth defects identified from the perinatal period up to one year of life. The registry is part of a Risk Evaluation and Mitigation Strategy (REMS) mandated by the FDA for mycophenolate formulations. Data will be collected at various gestational time points to assess the impact of mycophenolate exposure on pregnancy.
Who should consider this trial
Good fit: Ideal candidates for this registry are pregnant women who have been exposed to mycophenolate during their pregnancy or within six weeks of stopping the medication.
Not a fit: Patients who are pregnant but have only paternal exposure to mycophenolate or those whose pregnancies occur outside the U.S. may not benefit from this registry.
Why it matters
Potential benefit: If successful, this registry could provide critical insights into the safety of mycophenolate use during pregnancy, guiding treatment decisions for women with autoimmune diseases or those undergoing organ transplantation.
How similar studies have performed: While this registry is part of a comprehensive REMS plan, similar observational studies have been conducted to assess medication safety during pregnancy, indicating a precedent for this type of research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnancy and reported maternal exposure to mycophenolate during pregnancy or within 6 weeks of discontinuing treatment Exclusion Criteria: * Pregnancies for which there is paternal exposure only * Pregnancies occurring outside the U.S.
Where this trial is running
Cambridge, Massachusetts
- Quintiles Outcome — Cambridge, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Reference Study ID Number: ML22679 https://forpatients.roche.com/
- Email: global-roche-genentech-trials@gene.com
- Phone: 888-662-6728 (U.S. and Canada)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.