Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
- Conditions
- Pregnancy Related
- Interventions
- Registration Number
- NCT03992729
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
This study will utilize a prospective, observational, exposure cohort design to examine pregnancy and infant outcomes in women and infants who are exposed to tildrakizumab during pregnancy to treat an approved indication.
The pregnancy registry cohort study will be conducted by the Organization of Teratology Information Specialists (OTIS), which is a network of university and health department based information centers serving pregnant women and healthcare providers throughout North America. These services provide a basis for collaborative research such as this Registry.
These Services located throughout the United States (US) and Canada will serve as a source of referrals not only for tildrakizumab-exposed pregnancies but also for similarly ascertained disease-matched comparison pregnant women who have not used tildrakizumab in pregnancy.
The target follow-up period will be until end of pregnancy and 1 year of age for live born infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 200
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tildrakizumab-Exposed Cohort Pregnant women exposed to tildrakizumab Exposure to tildrakizumab for the treatment of an approved indication Disease-Matched Comparison Cohort Pregnant women not exposed to tildrakizumab No exposure to tildrakizumab at any time in the current pregnancy
- Primary Outcome Measures
Name Time Method Major structural defects in children Up to 1 year of age defined and classified using the US Centers for Disease Control and Prevention (CDC) coding manual that is used for the Metropolitan Atlanta Congenital Defects Program (MACDP) classification of major structural defects
- Secondary Outcome Measures
Name Time Method Postnatal growth deficiency Up to 1 year of age defined as postnatal size (weight, length or head circumference) less than or equal to the 10th centile for sex and age using standard pediatric growth curves and adjusted for postnatal age for premature infants if the postnatal measurement is obtained at less than 1 year of age
Spontaneous abortion/miscarriage 20 weeks post-last menstrual period defined as non-deliberate fetal death that occurs prior to 20.0 weeks post-last menstrual period
Stillbirth from 20 weeks post-last menstrual period to end of pregnancy defined as non-deliberate fetal death anytime in gestation at or after 20.0 weeks post-last menstrual period
Elective termination/abortion At the end of pregnancy or through 9 month pregnancy period defined as deliberate discontinuation of pregnancy through medication or surgical procedures
neonatal/infant death 6 months of age defined as any death in a live born infant during the first 6 months of age
Small for gestational age at birth defined as birth size (weight, length, or head circumference) less than or equal to the 10th centile for sex and gestational age using standard pediatric CDC growth curves for full term or preterm infants
Malignancies in live born children Up to 1 year of age defined as any malignancy reported in an infant within the first year of life
Hospitalization in live born children Up to 1 year of age defined as any hospitalization of the infant within the first year of life after discharge following delivery
Postnatal serious or opportunistic infection in live born children Up to 1 year defined as any infection resulting in hospitalization, X-ray proven pneumonia, neonatal sepsis, meningitis, osteomyelitis, bacteremia, septic arthritis, abscess, mycobacteria infections, invasive fungal infection including histoplasmosis, coccidiomycosis, candidiasis, aspergillosis, and blastomycosis, pneumocystis jirovecii infection, systemic cytomegalovirus, herpes zoster and herpes simplex infection, listeria infections, and Legionella infection.
Trial Locations
- Locations (1)
Christina Chambers
🇺🇸San Diego, California, United States