A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab (PETUNIA)
30 de octubre de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Estado
Aún no reclutando
Condiciones
Condiciones
Tipo de estudio
Tipo de estudio
De observación
Inscripción (Estimado)
Inscripción
162
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
Estudio Contacto
- Nombre: Study Contact
- Número de teléfono: 844-434-4210
- Correo electrónico: Participate-In-This-Study1@its.jnj.com
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra no probabilística
Población de estudio
The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Número de grupos/cohortes
1
Cohortes e Intervenciones
Grupo / CohorteGrupo / 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prevalence of Fetal Growth Restriction
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Prevalence of Live Birth
Periodo de tiempo: At Delivery
|
Delivery of a live newborn. |
At Delivery
|
|
Prevalence of Spontaneous Abortion
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 28 days to 365 days after birth
|
Death that occurs between 28 and 365 days of life. |
28 days to 365 days after birth
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Patrocinador
Investigadores
Investigadores
- Director de estudio: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
Inicio del estudio
30 de noviembre de 2026
Finalización primaria (Estimado)
Finalización primaria
30 de abril de 2036
Finalización del estudio (Estimado)
Finalización del estudio
30 de abril de 2036
Fechas de registro del estudio
Enviado por primera vez
Enviado por primera vez
30 de octubre de 2026
Primero enviado que cumplió con los criterios de control de calidad
Primero enviado que cumplió con los criterios de control de calidad
30 de octubre de 2026
Publicado por primera vez (Actual)
Publicado por primera vez
4 de noviembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización publicada
4 de noviembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
Última actualización enviada que cumplió con los criterios de control de calidad
30 de octubre de 2026
Última verificación
Última verificación
1 de octubre de 2026
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
Otros números de identificación del estudio
- 80202135MYG4003
- 80202135MYG4003 (Otro identificador: Janssen Research & Development, LLC)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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