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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: Completed Phase 1 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Sample will be collected prior to the administration of study medication.
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 |
What the finished NCT01900574 record still lists
NCT01900574 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 405-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (91% lower).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01900574's enrollment target sits among peer trials
35 28th of 28 higher than 1 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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