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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05953402
Recruitment Status : Not yet recruiting
First Posted : July 20, 2023
Last Update Posted : July 20, 2023
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Study Description
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Brief Summary:
The purpose of this study is to evaluate association between ozanimod exposure during pregnancy and subsequent maternal, fetal, and infant outcomes.

Condition or disease
Ulcerative Colitis

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1182 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 21 Months
Official Title: ZEPOSIA® (Ozanimod) Ulcerative Colitis Pregnancy Registry: a Prospective, Observational Study on the Safety of Ozanimod Exposure in Pregnant Women With Ulcerative Colitis and Their Offspring
Estimated Study Start Date : September 6, 2023
Estimated Primary Completion Date : June 30, 2032
Estimated Study Completion Date : June 30, 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Ozanimod-exposed participants with UC
Pregnant women with a diagnosis of UC who are exposed to ozanimod at any time during pregnancy
Conventional therapy-exposed participants with UC
Pregnant women with a diagnosis of UC who are exposed to conventional therapies (aminosalicylates and/or thiopurines) but not exposed to ozanimod, other S1P therapies, or advanced therapies for UC (biologics and/or small molecules) at any time during pregnancy
Advanced therapy-exposed participants with UC
Pregnant women with a diagnosis of UC who are exposed to advanced therapies for UC (biologics and/or small molecules) but not exposed to ozanimod or other S1P therapies at any time during pregnancy


Outcome Measures
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Primary Outcome Measures :
  1. Event rate of Major Congenital Malformations (MCM) [ Time Frame: Up to 12 months ]

Secondary Outcome Measures :
  1. Event rate of minor congenital malformations [ Time Frame: Up to 12 months ]
  2. Event rate of pre-eclampsia [ Time Frame: Up to 9 months ]
  3. Event rate of eclampsia [ Time Frame: Up to 9 months ]
  4. Event rate of Spontaneous Abortion (SAB) [ Time Frame: Up to 9 months ]
  5. Event rate of stillbirth [ Time Frame: Up to 9 months ]
  6. Event rate of elective termination [ Time Frame: Up to 9 months ]
  7. Event rate of preterm birth [ Time Frame: Up to 9 months ]
  8. Event rate of Small for Gestational Age (SGA) [ Time Frame: Up to 12 months ]
  9. Event rate of postnatal growth deficiency [ Time Frame: Up to 12 months ]
  10. Event rate of infant developmental deficiency [ Time Frame: Up to 12 months ]
  11. Event rate of perinatal death [ Time Frame: Up to 10 months ]
  12. Event rate of neonatal death [ Time Frame: Up to 1 month ]
  13. Event rate of infant death [ Time Frame: Up to 12 months ]
  14. Event rate of serious or opportunistic infant infections [ Time Frame: Up to 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population will include women of any age who i) are currently or recently have been pregnant; ii) have a diagnosis of UC; iii) reside in a country where ozanimod is prescribed for the treatment of UC; iv) provide consent to participate as well as medical releases for their Healthcare Providers (HCPs) to provide data to the registry; and v) meet the criteria for inclusion.
Criteria

Inclusion Criteria:

  • Currently or recently pregnant
  • Diagnosis of UC
  • Resident of country where ozanimod is prescribed for the treatment of UC

Exclusion Criteria:

  • Exposure to other S1P therapies at any time during pregnancy

Other protocol-defined eligibility criteria apply.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05953402


Contacts
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Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com 855-907-3286 Clinical.Trials@bms.com
Contact: First line of the email MUST contain the NCT# and Site #.

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT05953402    
Other Study ID Numbers: IM047-026
First Posted: July 20, 2023    Key Record Dates
Last Update Posted: July 20, 2023
Last Verified: July 2023
Keywords provided by Bristol-Myers Squibb:
ZEPOSIA®
Ozanimod
Pregnancy
Sphingosine-1-phosphate (S1P) therapies
 Inflammatory Bowel Disease
IBD
Ulcerative Colitis
UC
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases