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NCT01900574 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
A Phase 1 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 35
- Enrollment target
- 20
- Study locations
NCT01900574 is a Phase 1 study of Colitis, Ulcerative that has completed, run by Janssen Research & Development. The registered enrollment target is 35 participants, below the 405-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01900574, a Phase 1 study of Colitis, Ulcerative, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 35 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).
Conditions Studied
Interventions
- DRUG Golimumab
Study Locations (20)
Other
- - Graz
- - Vienna
- - Brussels
- - Aarhus
- - Hvidovre
- - Paris
- - Aachen
- - München
California
- - Los Angeles
- - San Francisco
Arizona
- - Phoenix
Connecticut
- - Hartford
Georgia
- - Atlanta
Illinois
- - Chicago
Minnesota
- - Rochester
New Jersey
- - Morristown
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2013-08-09 |
| Est. Completion | 2022-09-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01900574
The ClinicalTrials.gov registry entry for NCT01900574 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 405-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (91% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 1 intervention - of which Golimumab is the first listed.
NCT01900574 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Other, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT01900574 about?
NCT01900574 is a clinical study titled "A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis". The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with moderately to severely active Ulcerative Colitis (UC).
What is the current status of trial NCT01900574?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 35 participants. The study started on 2013-08-09. Estimated completion is 2022-09-01.
What conditions does trial NCT01900574 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT01900574?
The interventions under investigation include: Golimumab (DRUG).
Who is sponsoring clinical trial NCT01900574?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01900574 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.