Pregnancy Related
Conditions
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.
Interventions
DRUGPregnant women exposed to tildrakizumab
Subjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
DRUGPregnant women not exposed to tildrakizumab
Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
Sponsors
Sun Pharmaceutical Industries Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
Cohort 1: Tildrakizumab-Exposed Cohort 1. Pregnant women 2. Exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period up to and including the end of pregnancy 3. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records Cohort 2: Disease-Matched Comparison Cohort 1. Pregnant women 2. Diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible 3. No exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy 4. Agree to the conditions and requirements of the study including the interview schedule, and release of medical records
Exclusion criteria
Cohort 1: Tildrakizumab-Exposed Cohort: 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect 2. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study) 3. Women who have used tildrakizumab for an indication other than a currently approved indication 4. Retrospective enrollment after the outcome of pregnancy is known Cohort 2: Disease-Matched Comparison Cohort 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect 2. Exposure to tildrakizumab anytime during the current pregnancy 3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study) 4. Retrospective enrollment after the outcome of pregnancy is known
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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. |
Countries
United States
Contacts
CONTACTHead, Clinical Development
Outcome results
None listed