NCT06126835Active, not recruiting
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
Source: ClinicalTrials.gov · Last updated 1 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2828 (estimated)
- First submitted
- 6 Oct 2023
- Start date
- 26 Aug 2024
- Primary completion date
- 31 May 2031
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Ulcerative colitis
- NCT number
- NCT06126835
What you commit to
- Study type: Observational
- Planned participants: 2828
- From 26 Aug 2024 to the primary completion date, 31 May 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- • Pregnancies exposed to any known teratogens and the exposure falls within the period of 5 half-lives prior to the estimated date of conception through the end of the first trimester (assessed via the presence of national drug codes or medical procedure codes)
Who the study is looking for
- Age 18 to 49 years on date of conception
- Date of conception between June 1, 2021 and September 1, 2030
- Continuous medical and pharmacy coverage for a minimum of 6 months prior to date of last menstrual period through the end of the pregnancy episode
- Diagnosis of UC during the 12 months prior to conception through the end of the first trimester
Age in the registry: 18 years to 49 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OptumInsight Life Sciences Inc Coordinator of this site? Confirm its status | Eden Prairie | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.