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NCT06126835 · ClinicalTrials.gov registry record
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
A clinical trial of Ulcerative Colitis, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- 2,828
- Enrollment target
- 1
- Study location
NCT06126835: Active study of Ulcerative Colitis, sponsored by Bristol-Myers Squibb.
NCT06126835 is a study of Ulcerative Colitis that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 2,828 participants, above the 2,034-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (39% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06126835, a study of Ulcerative Colitis, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- 2,828 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the third is women with UC exposed to advanced therapy during pregnancy. This study will use data from a large US healthcare claims database.
Primary Outcome
To estimate and compare the prevalence of major congenital malformations among infants born to pregnant women with UC who were exposed to ozanimod during first trimester relative to the prevalence among (i) infants born to women with UC exposed to conventional UC treatments and (ii) infants born to women with UC exposed to advanced UC treatment during first trimester of pregnancy.
Conditions Studied
Interventions
- DRUG Ozanimod
- DRUG Conventional therapy
- DRUG Advanced therapy
Study Locations (1)
Minnesota
- OptumInsight Life Sciences Inc - Eden Prairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,828 participants |
| Start Date | 2024-08-26 |
| Est. Completion | 2032-06-30 |
What the registry record for NCT06126835 still lists
NCT06126835 is an observational study that tracks outcomes without assigning an intervention. Its 2,828 participants enrollment target places it among the larger protocols in the corpus, above the 2,034-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (39% higher).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 3 interventions - of which Ozanimod is the first listed.
NCT06126835 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06126835 about?
NCT06126835 is a clinical study titled "A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants". The purpose of this retrospective observational cohort study is to assess pregnancy and infant outcomes in three groups: the first is women with ulcerative colitis (UC) who were exposed to ozanimod during pregnancy; the second is women with UC exposed to conventional therapy during pregnancy; the th...
What is the current status of trial NCT06126835?
This trial is currently active not recruiting. The enrollment target is 2,828 participants. The study started on 2024-08-26. Estimated completion is 2032-06-30.
What conditions does trial NCT06126835 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT06126835?
The interventions under investigation include: Ozanimod (DRUG), Conventional therapy (DRUG), Advanced therapy (DRUG).
Who is sponsoring clinical trial NCT06126835?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06126835 being conducted?
This trial has 1 study location across Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06126835's enrollment target sits among peer trials
2,828 4th of 122 higher than 119 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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