OTIS Vedolizumab Pregnancy Exposure Registry

• Status: Active, not recruiting
• Trial end date: 2023-08-31
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the prevalence of major structural birth defects in infants of female participants with ulcerative colitis (UC) or Crohn's disease (CD) exposed to vedolizumab during pregnancy, compared to participants with UC or CD exposed to other biologic agents.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Takeda
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is a currently pregnant woman with UC or CD,

2. Has exposure to Entyvio or other biologic agents at any dose, and at any time from first day of LMP,

3. Has enrolled no later than 19 completed weeks after LMP.

4. Agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.

For the 'no chronic disease' Prospective Cohort:

5. Is a currently pregnant woman with no chronic disease.

6. Has no exposure to any biological agent and at any time from first day of LMP,

7. Has enrolled no later than 19 completed weeks after LMP.

8. Agrees to the conditions and requirements of the study including the interview schedule, release of medical records, and the physical examination of live born infants.

Exclusion Criteria:

For the UC/CD Prospective Cohort:

1. Is greater than (>) 19 completed weeks gestation prior to enrollment,

2. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

3. Has enrolled in this registry with a previous pregnancy,

4. Has had an exposure to the known or suspected human teratogens: Chlorambucil. Cyclophosphamide, Mycophenylate mofetil.

For the 'no chronic disease' Prospective Cohort:

5. Is >19 completed weeks gestation prior to enrollment,

6. Has first contact with OTIS after prenatal diagnosis of any major structural defect,

7. Has enrolled in this registry with a previous pregnancy,

8. Has had an exposure to the known or suspected human teratogens: Chlorambucil, Cyclophosphamide, Mycophenylate mofetil.

Note: women exposed to Entyvio during pregnancy but not meeting the above criteria can enroll into the Entyvio pregnancy exposure case series component of this registry.