A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2828 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-26

Study Completion Date

2032-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring

NCT05953402

Ulcerative Colitis

NOT_YET_RECRUITING

An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice

NCT05369832

Colitis, Ulcerative

TERMINATED PHASE4

A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

NCT05076175

Colitis, Ulcerative

RECRUITING PHASE2/PHASE3

A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis

NCT05382715

Colitis, Ulcerative

TERMINATED

Efficacy and Safety Study of Ozanimod in Ulcerative Colitis

NCT01647516

Ulcerative Colitis

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ozanimod exposed

Ozanimod

Intervention Type DRUG

Women with UC exposed to ozanimod during pregnancy

Conventional therapy exposed

Conventional therapy

Intervention Type DRUG

Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy

Advanced therapy exposed

Advanced therapy

Intervention Type DRUG

Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ozanimod

Women with UC exposed to ozanimod during pregnancy

Intervention Type DRUG

Conventional therapy

Women with UC exposed to conventional therapy (aminosalicylates, azathioprine, or mercaptopurine) during pregnancy

Intervention Type DRUG

Advanced therapy

Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* • 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No