Assessing pregnancy outcomes in women treated with tildrakizumab
Post-authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
This study is trying to see how pregnancy and baby outcomes are affected in women who took tildrakizumab compared to those who didn't.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | Female |
| Sponsor | Sun Pharmaceutical Industries Limited Industry-sponsored |
| Drugs / interventions | Tildrakizumab |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT03992729 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate pregnancy and infant outcomes in women who have been treated with tildrakizumab during pregnancy. It will utilize a prospective, observational, exposure cohort design, comparing outcomes between women exposed to tildrakizumab and a disease-matched comparison group who have not used the medication. The study will be conducted by the Organization of Teratology Information Specialists (OTIS) across various locations in North America, with follow-up extending until the end of pregnancy and one year of age for live-born infants. Participants will be recruited from a network of university and health department-based information centers.
Who should consider this trial
Good fit: Ideal candidates include pregnant women who have been treated with tildrakizumab or those diagnosed with a tildrakizumab-approved indication but have not been exposed to the medication during their current pregnancy.
Not a fit: Patients who are not pregnant or those who have not been treated with tildrakizumab for an approved indication may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety of tildrakizumab during pregnancy, guiding treatment decisions for pregnant women with approved indications.
How similar studies have performed: Other studies have successfully assessed pregnancy outcomes in similar contexts, but this specific approach to evaluating tildrakizumab exposure is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Diego, California
- Christina Chambers — San Diego, California, United States (Recruiting)
Study contacts
- Study coordinator: Head, Clinical Development
- Email: Clinical.Trial@sunpharma.com
- Phone: 91 2266455645
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.