RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab

Quick Facts

Study Start:2019-08-29
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03992729

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
  2. 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. 3. Women who have used tildrakizumab for an indication other than a currently approved indication
  4. 4. Retrospective enrollment after the outcome of pregnancy is known
  5. 1. Women who have first contact with the project after prenatal diagnosis of any major structural defect
  6. 2. Exposure to tildrakizumab anytime during the current pregnancy
  7. 3. Women who have enrolled in the tildrakizumab cohort study with a previous pregnancy (women may only enroll once in the Tildrakizumab Pregnancy Study)
  8. 4. Retrospective enrollment after the outcome of pregnancy is known

Contacts and Locations

Study Contact

Head, Clinical Development
CONTACT
91 2266455645
Clinical.Trial@sunpharma.com

Study Locations (Sites)

Christina Chambers
San Diego, California, 92093
United States

Collaborators and Investigators

Sponsor: Sun Pharmaceutical Industries Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-29
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2019-08-29
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Pregnancy Related