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NCT02678052 · ClinicalTrials.gov registry record
OTIS Vedolizumab Pregnancy Exposure Registry
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 303
- Enrollment target
NCT02678052 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 303 participants.
The verdict
NCT02678052 has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- 303 participants
- Enrollment target
Study 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.
Interventions
- DRUG Vedolizumab
- BIOLOGICAL Other Biological Agent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2015-12-01 |
| Est. Completion | 2022-07-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02678052
The ClinicalTrials.gov registry entry for NCT02678052 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Takeda, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vedolizumab is the first listed.
NCT02678052 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02678052 about?
NCT02678052 is a clinical study titled "OTIS Vedolizumab Pregnancy Exposure Registry". 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.
What is the current status of trial NCT02678052?
This trial is currently completed. The enrollment target is 303 participants. The study started on 2015-12-01. Estimated completion is 2022-07-31.
What interventions are being tested in trial NCT02678052?
The interventions under investigation include: Vedolizumab (DRUG), Other Biological Agent (BIOLOGICAL).
Who is sponsoring clinical trial NCT02678052?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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