A Study to Assess Pregnancy, Neonatal and Infant Outcomes in Participants Exposed to Nipocalimab (PETUNIA)
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.
Přehled studie
Postavení
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Study Contact
- Telefonní číslo: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Popis
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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
|---|
|
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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Prevalence of Fetal Growth Restriction
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Prevalence of Live Birth
Časové okno: At Delivery
|
Delivery of a live newborn. |
At Delivery
|
|
Prevalence of Spontaneous Abortion
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 28 days to 365 days after birth
|
Death that occurs between 28 and 365 days of life. |
28 days to 365 days after birth
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Ředitel studie: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 80202135MYG4003
- 80202135MYG4003 (Jiný identifikátor: Janssen Research & Development, LLC)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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