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

30 octobre 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Type d'étude

Observationnel

Inscription (Estimé)

162

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant
  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Femelle

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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

La description

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)

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Modèles d'observation: COHORT
  • Perspectives temporelles: PROSPECTIVE

Cohortes et interventions

Groupe / Cohorte
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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Prevalence of Fetal Growth Restriction
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Prevalence of Live Birth
Délai: At Delivery

Delivery of a live newborn.
At Delivery
Prevalence of Spontaneous Abortion
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 28 days to 365 days after birth

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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Janssen Research & Development, LLC

Les enquêteurs

  • Directeur d'études: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

30 novembre 2026

Achèvement primaire (Estimé)

30 avril 2036

Achèvement de l'étude (Estimé)

30 avril 2036

Dates d'inscription aux études

Première soumission

30 octobre 2026

Première soumission répondant aux critères de contrôle qualité

30 octobre 2026

Première publication (Réel)

4 novembre 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

4 novembre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 octobre 2026

Dernière vérification

1 octobre 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • 80202135MYG4003
  • 80202135MYG4003 (Autre identifiant: Janssen Research & Development, LLC)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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