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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06126835




Registration number
NCT06126835
Ethics application status
Date submitted
6/10/2023
Date registered
13/11/2023

Titles & IDs
Public title
A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants
Scientific title
Ozanimod Pregnancy Safety Study in Pregnant Women With Ulcerative Colitis and Their Offspring
Secondary ID [1] 0 0
IM047-025
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Ozanimod
Treatment: Drugs - Conventional therapy
Treatment: Drugs - Advanced therapy

Ozanimod exposed -

Conventional therapy exposed -

Advanced therapy exposed -


Treatment: Drugs: Ozanimod
Women with UC exposed to ozanimod during pregnancy

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

Treatment: Drugs: Advanced therapy
Women with UC exposed to advanced therapy (infliximab, adalimumab, golimumab, vedolizumab, ustekinumab, tofacitinib, cyclosporine, or tacrolimus) during pregnancy
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Prevalence of major congenital malformations among infants
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [1] 0 0
Number of spontaneous abortions
Timepoint [1] 0 0
Up to 10 years
Secondary outcome [2] 0 0
Number of stillbirths
Timepoint [2] 0 0
Up to 10 years
Secondary outcome [3] 0 0
Number of participants with pre-eclampsia
Timepoint [3] 0 0
Up to 10 years
Secondary outcome [4] 0 0
Number of participants with eclampsia
Timepoint [4] 0 0
Up to 10 years
Secondary outcome [5] 0 0
Number of preterm births
Timepoint [5] 0 0
Up to 10 years
Secondary outcome [6] 0 0
Number of infants small for gestational age
Timepoint [6] 0 0
Up to 10 years
Secondary outcome [7] 0 0
Number of serious or opportunistic infections in liveborn infants up to 1 year of age
Timepoint [7] 0 0
Up to 10 years
Secondary outcome [8] 0 0
Number of infant postnatal growth deficiencies
Timepoint [8] 0 0
Up to 10 years
Secondary outcome [9] 0 0
Number of infant developmental deficiencies
Timepoint [9] 0 0
Up to 10 years
Secondary outcome [10] 0 0
Number of neonatal hospitalizations
Timepoint [10] 0 0
Up to 10 years
Secondary outcome [11] 0 0
Number of infant deaths
Timepoint [11] 0 0
Up to 10 years
Secondary outcome [12] 0 0
Number of neonatal deaths
Timepoint [12] 0 0
Up to 10 years
Secondary outcome [13] 0 0
Number of perinatal deaths
Timepoint [13] 0 0
Up to 10 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
49 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2032
Actual
Sample size
Target
2828
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Minnesota

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06126835