Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00116272 · ClinicalTrials.gov registry record
Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project
A clinical trial, sponsored by Amgen.
- Completed
- Registry status
- 830
- Enrollment target
NCT00116272: Completed study, sponsored by Amgen.
NCT00116272 is a clinical trial that has completed, run by Amgen. The registered enrollment target is 830 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00116272 has completed, sponsored by Amgen.
- COMPLETED
- Registry status
- 830 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.
Primary Outcome
A major structural defect is defined as a defect which has either cosmetic or functional significance to the child (e.g., a cleft lip). The Registry used the Metropolitan Atlanta Congenital Defects Program (MACDP) birth defect classification system, with some specified modifications that are appropriate for cohort studies as opposed to case-control studies.
Interventions
- DRUG Etanercept
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 830 participants |
| Start Date | 2005-04 |
| Est. Completion | 2014-06 |
What the finished NCT00116272 record still lists
NCT00116272 is an observational study that tracks outcomes without assigning an intervention. The registered 830 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Etanercept is the first listed.
NCT00116272 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00116272 about?
NCT00116272 is a clinical study titled "Organization of Teratology Information Services (OTIS) Autoimmune Diseases in Pregnancy Project". The purpose of the study is to evaluate the effect of etanercept when used in the first trimester of pregnancy with respect to major structural birth defects of newborns. This is an observational study only - no investigational product is used.
What is the current status of trial NCT00116272?
This trial is currently completed. The enrollment target is 830 participants. The study started on 2005-04. Estimated completion is 2014-06.
What interventions are being tested in trial NCT00116272?
The interventions under investigation include: Etanercept (DRUG).
Who is sponsoring clinical trial NCT00116272?
This trial is sponsored by Amgen, which has 558 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
- NCT05067283 · 830 participants · Phase 1
A Study of Calderasib (MK-1084) in KRAS Mutant Advanced Solid Tumors (MK-1084-001)
- NCT06592924 · 830 participants · Phase 3
Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response
- NCT06868277 · 830 participants · Phase 3
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer
- NCT06910553 · 832 participants
IBD Pregnancy Registry
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia