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

30 oktober 2026 bijgewerkt door: Janssen Research & Development, LLC

Nipocalimab Pregnancy Enhanced Tracking With Neonatal and Infant Assessment

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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Studietype

Observationeel

Inschrijving (Geschat)

162

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.

Beschrijving

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)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: COHORT
  • Tijdsperspectieven: PROSPECTIVE

Cohorten en interventies

Groep / Cohort
Participants Exposed to Nipocalimab Immediately Before or During Pregnancy

Participants with documented exposure to at least one dose of nipocalimab any time immediately before (within 1 week [7 days] before estimated date of conception) or during pregnancy in the post-marketing setting. No drug will be administered as a part of this study. Participants received nipocalimab as per their routine clinical practice settings.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prevalence of Fetal Growth Restriction
Tijdsspanne: During pregnancy (Up to Week 42)

A fetus with an estimated fetal weight less than the 10th percentile for gestational age based upon a population reference or standard.
During pregnancy (Up to Week 42)
Prevalence of Small for Gestational Age
Tijdsspanne: At birth

A newborn with a birthweight less than the 10th percentile for gestational age based upon a population reference or standard.
At birth
Prevalence of Hypertensive Disorders of Pregnancy
Tijdsspanne: From 20 weeks gestation through 6 weeks postpartum

Hypertensive disorder of pregnancy (that is, preeclampsia, gestational hypertension, hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome, or eclampsia).
From 20 weeks gestation through 6 weeks postpartum
Prevalence of Placental Abruption
Tijdsspanne: During pregnancy (Up to Week 42)

A condition in which the placenta has begun to separate from the uterus before the fetus is born.
During pregnancy (Up to Week 42)
Prevalence of Serious Infections in Neonates
Tijdsspanne: Birth to 27 days

Infections resulting in a hospitalization that occur within the first 27 days of life (0-27 days).
Birth to 27 days
Prevalence of Serious Infections in Infants
Tijdsspanne: 28 days to 365 days after birth

Infections resulting in a hospitalization that occur between 28 and 365 days of life.
28 days to 365 days after birth
Prevalence of Non-chromosomal Major Congenital Malformations
Tijdsspanne: During pregnancy (up to Week 42) and up to 1 year after birth

Congenital abnormality that requires medical or surgical treatment, has a serious adverse effect on health and development, or has significant cosmetic impact, excluding those that are chromosomal or Mendelian-inherited anomalies.
During pregnancy (up to Week 42) and up to 1 year after birth

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Prevalence of Live Birth
Tijdsspanne: At Delivery

Delivery of a live newborn.
At Delivery
Prevalence of Spontaneous Abortion
Tijdsspanne: Prior to 20 weeks gestation

Clinically detected pregnancy loss before 20 completed weeks of gestation that occurs without medical or surgical intervention to terminate the pregnancy.
Prior to 20 weeks gestation
Prevalence of Stillbirth
Tijdsspanne: At or after 20 completed weeks of gestation

Fetus born dead at >= 20 weeks gestation or weighing >= 350 grams. Fetal death occurring > 20 weeks but less than 28 weeks gestation is considered an early fetal loss. Fetal death occurring > 28 weeks is considered a late fetal loss. If gestational age is unknown, stillbirth refers to a fetus weighing >= 350 grams.
At or after 20 completed weeks of gestation
Prevalence of Preterm Birth
Tijdsspanne: Prior to 37 completed weeks of gestation

Delivery of a viable infant before 37 completed weeks of gestation.
Prior to 37 completed weeks of gestation
Prevalence of Intrapartum Hemorrhage
Tijdsspanne: During pregnancy (Up to 42 weeks)

Maternal complication characterized by significant blood loss occurring during pregnancy.
During pregnancy (Up to 42 weeks)
Prevalence of Postpartum Hemorrhage
Tijdsspanne: At Birth and after 12 weeks delivery

Maternal complication characterized by significant blood loss occurring after pregnancy.
At Birth and after 12 weeks delivery
Prevalence of Neonatal Death
Tijdsspanne: Birth to 27 days

Death that occurs within the first 27 days of life (0-27 days).
Birth to 27 days
Prevalence of Infant Death
Tijdsspanne: 28 days to 365 days after birth

Death that occurs between 28 and 365 days of life.
28 days to 365 days after birth

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Janssen Research & Development, LLC

Onderzoekers

  • Studie directeur: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 november 2026

Primaire voltooiing (Geschat)

30 april 2036

Studie voltooiing (Geschat)

30 april 2036

Studieregistratiedata

Eerst ingediend

30 oktober 2026

Eerst ingediend dat voldeed aan de QC-criteria

30 oktober 2026

Eerst geplaatst (Werkelijk)

4 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

4 november 2026

Laatste update ingediend die voldeed aan QC-criteria

30 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • 80202135MYG4003
  • 80202135MYG4003 (Andere identificatie: Janssen Research & Development, LLC)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The data sharing policy of Johnson & Johnson Innovative Medicine is available at www.jnj.com/innovativemedicine/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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