Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

Part of paid clinical trials in San Diego, California.

Sponsor
Sun Pharmaceutical Industries Limited
Study ID
NCT03992729
Status
Recruiting
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Conditions

  • Pregnancy Related

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pregnant women exposed to tildrakizumab — DRUG
    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
  • Pregnant women not exposed to tildrakizumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Aug 29, 2019
Status verified
Jan 2026
Primary completion
Jul 31, 2028
Completion
Jul 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: Tildrakizumab-Exposed Cohort
    Exposure to tildrakizumab for the treatment of an approved indication
  • Arm: Disease-Matched Comparison Cohort
    No exposure to tildrakizumab at any time in the current pregnancy

Primary Outcome Measure

Major structural defects in children [ Time Frame: Up to 1 year of age ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Christina ChambersSan DiegoCalifornia92093-

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Christina Chambers· San Diego, CA

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