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NCT06133049 · ClinicalTrials.gov registry record
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis and Their Infants
A clinical trial of Multiple Sclerosis, sponsored by Bristol-Myers Squibb.
- Active
- Registry status
- 2,961
- Enrollment target
- 1
- Study location
NCT06133049: Active study of Multiple Sclerosis, sponsored by Bristol-Myers Squibb.
NCT06133049 is a study of Multiple Sclerosis that is active but no longer recruiting, run by Bristol-Myers Squibb. The registered enrollment target is 2,961 participants, above the 576-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (414% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06133049, a study of Multiple Sclerosis, is active but no longer recruiting, sponsored by Bristol-Myers Squibb.
- ACTIVE NOT RECRUITING
- Registry status
- 2,961 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 multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMTs) during pregnancy; the third is women with MS not exposed to any DMTs during pregnancy. This study will use data from a large US healthcare claims database.
Primary Outcome
Prevalence of major congenital malformations among infants born to women with MS exposed to ozanimod during the first trimester, and to compare this to the prevalence among each of the two comparator groups of pregnant women (other DMT exposed or NO DMT exposed)
Conditions Studied
Interventions
- DRUG Ozanimod
- DRUG Select DMTs other than ozanimod
- DRUG No DMTs
Study Locations (1)
Minnesota
- OptumInsight Life Sciences Inc - Eden Prairie
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,961 participants |
| Start Date | 2021-03-16 |
| Est. Completion | 2031-08-31 |
What the registry record for NCT06133049 still lists
NCT06133049 is an observational study that tracks outcomes without assigning an intervention. Its 2,961 participants enrollment target places it among the larger protocols in the corpus, above the 576-participant average among 315 other Multiple Sclerosis trials with a reported enrollment target (414% higher).
The record links to 1 condition, with Multiple Sclerosis appearing as the primary indexed condition, and to 3 interventions - of which Ozanimod is the first listed.
NCT06133049 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT06133049 about?
NCT06133049 is a clinical study titled "A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Multiple Sclerosis 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 multiple sclerosis (MS) who were exposed to ozanimod during pregnancy; the second is women with MS exposed to select other disease-modifying therapies (DMT...
What is the current status of trial NCT06133049?
This trial is currently active not recruiting. The enrollment target is 2,961 participants. The study started on 2021-03-16. Estimated completion is 2031-08-31.
What conditions does trial NCT06133049 study?
This clinical trial studies the following conditions: Multiple Sclerosis.
What interventions are being tested in trial NCT06133049?
The interventions under investigation include: Ozanimod (DRUG), Select DMTs other than ozanimod (DRUG), No DMTs (DRUG).
Who is sponsoring clinical trial NCT06133049?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06133049 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
Similar trials for Multiple Sclerosis
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 NCT06133049's enrollment target sits among peer trials
2,961 11th of 315 higher than 305 of 315 other Multiple Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Multiple Sclerosis 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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