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NCT02103361 · ClinicalTrials.gov registry record
Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
A clinical trial of Pregnancy and Psoriasis, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- 200
- Enrollment target
- 1
- Study location
NCT02103361: Recruiting study of Pregnancy and Psoriasis, sponsored by University of California, San Diego.
NCT02103361 is a study of Pregnancy and Psoriasis that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 200 participants, below the 872-participant average among 191 other Pregnancy trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02103361, a study of Pregnancy and Psoriasis, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it is important to evaluate the spectrum of outcomes that may be relevant to a medication exposure during pregnancy, and these include both easily recognizable defects which are visible at birth, as well as more subtle or delayed defects that may not be readily identifiable without special expertise and observation beyond the newborn period.
Primary Outcome
The primary objective of the study is to evaluate the effect of certain medications when used in the first trimester of pregnancy with respect to major structural birth defects.
Conditions Studied
Interventions
- DRUG Ustekinumab
- DRUG Guselkumab
Study Locations (1)
California
- University of California, San Diego - La Jolla
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2013-11 |
| Est. Completion | 2031-02 |
What NCT02103361 shows while recruiting
NCT02103361 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 872-participant average among 191 other Pregnancy trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Pregnancy appearing as the primary indexed condition, and to 2 interventions - of which Ustekinumab is the first listed.
NCT02103361 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT02103361 about?
NCT02103361 is a clinical study titled "Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project". The purpose of the OTIS Autoimmune Diseases in Pregnancy Study is to monitor planned and unplanned pregnancies exposed to certain medications, to evaluate the possible teratogenic effect of these medications and to follow live born infants for one year after birth. With respect to fetal outcome, it ...
What is the current status of trial NCT02103361?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2013-11. Estimated completion is 2031-02.
What conditions does trial NCT02103361 study?
This clinical trial studies the following conditions: Pregnancy, Psoriasis, Crohn Disease, Psoriatic Arthritis.
What interventions are being tested in trial NCT02103361?
The interventions under investigation include: Ustekinumab (DRUG), Guselkumab (DRUG).
Who is sponsoring clinical trial NCT02103361?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02103361 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
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 NCT02103361's enrollment target sits among peer trials
200 84th of 191 higher than 103 of 191 other Pregnancy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pregnancy 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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