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NCT03992729 · ClinicalTrials.gov registry record
Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab
A clinical trial of Pregnancy Related, sponsored by Sun Pharmaceutical Industries Limited.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT03992729: Recruiting study of Pregnancy Related, sponsored by Sun Pharmaceutical Industries Limited.
NCT03992729 is a study of Pregnancy Related that is actively recruiting participants, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 200 participants, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03992729, a study of Pregnancy Related, is actively recruiting participants, sponsored by Sun Pharmaceutical Industries Limited.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Pregnant women exposed to tildrakizumab
- DRUG Pregnant women not exposed to tildrakizumab
Study Locations (1)
California
- Christina Chambers - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2019-08-29 |
| Est. Completion | 2028-07-31 |
What NCT03992729 shows while recruiting
NCT03992729 is an observational study that tracks outcomes without assigning an intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,961-participant average among 99 other Pregnancy Related trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Pregnancy Related appearing as the primary indexed condition, and to 2 interventions - of which Pregnant women exposed to tildrakizumab is the first listed.
NCT03992729 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT03992729 about?
NCT03992729 is a clinical study titled "Safety Study for Prospective Assessment of Pregnancy Outcomes in Patients Treated With Tildrakizumab". 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 ...
What is the current status of trial NCT03992729?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2019-08-29. Estimated completion is 2028-07-31.
What conditions does trial NCT03992729 study?
This clinical trial studies the following conditions: Pregnancy Related.
What interventions are being tested in trial NCT03992729?
The interventions under investigation include: Pregnant women exposed to tildrakizumab (DRUG), Pregnant women not exposed to tildrakizumab (DRUG).
Who is sponsoring clinical trial NCT03992729?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03992729 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pregnancy Related
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03992729's enrollment target sits among peer trials
200 44th of 99 higher than 55 of 99 other Pregnancy Related trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy Related trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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