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Not Yet Recruiting NCT07915232

A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab

Conditions: Pregnancy Related, Pregnancy, Pregnancy High-risk

Sex: Female
Healthy volunteers: No
Enrollment: 162
Sponsor: Janssen Research & Development, LLC

Summary

The purpose of this study is to find out how often: * Pregnancy problems, complications in mothers, and health issues in newborn babies occurred in participants who took nipocalimab just before or during pregnancy. * Serious infections occur in newborns and infants born to participants who took nipocalimab just before or during pregnancy. * Babies are born with major birth defects (not related to chromosomes) in pregnancies where nipocalimab was taken just before or during pregnancy.

Eligibility Criteria

Inclusion Criteria: \- Documented exposure to least one dose of nipocalimab any time immediately before ( 1 week \[7 days \] before estimated date of conception) or during pregnancy in the post-marketing setting Exclusion Criteria: * Reports in which the pregnant person discontinued nipocalimab 1 week (7 days) before the estimated date of conception * Indirect case reports (reported by someone other than the patient or the health care provider \[HCP\]) for which the reporter refuses to provide follow-up information, and the participants or HCP cannot be identified based on the information provided * Case lacking reporter contact details * Cases where only the father/male partner is exposed to nipocalimab during partner's pregnancy * Cases occurring in an interventional setting (that is, clinical trials)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07915232). StuddyBuddy aggregates publicly available trial information.