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.
Studieoversigt
Status
Betingelser
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Study Contact
- Telefonnummer: 844-434-4210
- E-mail: Participate-In-This-Study1@its.jnj.com
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
The study population are cases reported to the Company global safety database from post-marketing reports of exposure to nipocalimab during pregnancy.
Beskrivelse
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)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: COHORT
- Tidsperspektiver: PROSPECTIVE
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of Fetal Growth Restriction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Prevalence of Live Birth
Tidsramme: At Delivery
|
Delivery of a live newborn. |
At Delivery
|
|
Prevalence of Spontaneous Abortion
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 28 days to 365 days after birth
|
Death that occurs between 28 and 365 days of life. |
28 days to 365 days after birth
|
Samarbejdspartnere og efterforskere
Efterforskere
- Studieleder: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 80202135MYG4003
- 80202135MYG4003 (Anden identifikator: Janssen Research & Development, LLC)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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