Clinical trial NCT03992729: Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Official title: Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2019-06-20
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed with tildrakizumab-approved indication with and without tildrakizumab

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.


Eligibility 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

Primary outcomes:
measure: Major structural defects in children
timeFrame: Up to 1 year of age
Secondary outcomes:
measure: Spontaneous abortion/miscarriage
timeFrame: 20 weeks post-last menstrual period
measure: Stillbirth
timeFrame: from 20 weeks post-last menstrual period to end of pregnancy
measure: Elective termination/abortion
timeFrame: At the end of pregnancy or through 9 month pregnancy period
measure: neonatal/infant death
timeFrame: 6 months of age
measure: Small for gestational age
timeFrame: at birth
measure: Postnatal growth deficiency
timeFrame: Up to 1 year of age
measure: Malignancies in live born children
timeFrame: Up to 1 year of age
measure: Hospitalization in live born children
timeFrame: Up to 1 year of age
measure: Postnatal serious or opportunistic infection in live born children
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Christina Chambers
state: California
Study officials:
References: