Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02678052 · ClinicalTrials.gov registry record
OTIS Vedolizumab Pregnancy Exposure Registry
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 303
- Enrollment target
NCT02678052: Completed study, sponsored by Takeda.
NCT02678052 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 303 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A major structural defect is defined as a defect that has either cosmetic or functional significance to the child (eg, a cleft lip), as defined by the Centers for Disease Control and Prevention (CDC). These defects in aggregate typically occur in less than (\<) 4% of the general population. Over 100 specific structural defects are considered to be major. Baseline will be considered as the time of birth of child.
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 |
What the finished NCT02678052 record still lists
NCT02678052 is an observational study that tracks outcomes without assigning an intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Vedolizumab is the first listed.
NCT02678052 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05508971 · 303 participants · NA
Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)
- NCT04750616 · 304 participants · Phase 2
NAD+ Augmentation in Cardiac Surgery Associated Myocardial Injury Trial
- NCT04994717 · 304 participants · Phase 3
Study Comparing Blinatumomab Alternating With Low-intensity Chemotherapy Versus Standard of Care Chemotherapy for Older Adults With Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia
- NCT06036147 · 304 participants · NA
Concussion Health Improvement Program
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI