Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Description

The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

Conditions

Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), Neuromyelitis Optica Spectrum Disorder (NMOSD)

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Study Overview

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Study Details

Study overview

The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Condition
Ultomiris-exposed Pregnant/ Postpartum
Intervention / Treatment

-

Contacts and Locations

Boston

North American call center (NACC), Boston, Massachusetts, United States, 02210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
  • * Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate).
  • * Willing to provide contact information for the participant.
  • * Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if applicable to current local regulations.
  • * Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
  • * Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure \[prior to conception as LMP+14 days, or during breastfeeding\].)
  • * Use of Ultomiris per local product information (i.e., United States Prescribing Information \[USPI\] or summary of product characteristics \[SmPC\])
  • * Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study

Ages Eligible for Study

to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alexion Pharmaceuticals, Inc.,

Sydney Williams, PRINCIPAL_INVESTIGATOR, North American Coordinating Center (NACC)

Study Record Dates

2033-11-29