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NCT00487539 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 1,065
- Enrollment target
- 20
- Study locations
NCT00487539: Completed Phase 2 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT00487539 is a Phase 2 study of Colitis, Ulcerative that has completed, run by Janssen Research & Development. The registered enrollment target is 1,065 participants, above the 368-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (189% higher). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00487539, a Phase 2 study of Colitis, Ulcerative, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 1,065 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
Primary Outcome
Clinical response is defined as decrease from baseline in Mayo score by greater than or equal to 30 percent and greater than or equal to 3, with either a decrease from baseline in rectal bleeding sub-score of greater than or equal to 1 or a rectal bleeding sub-score of 0 or 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease.
Conditions Studied
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Golimumab 100 mg
- BIOLOGICAL Golimumab 200 mg
- BIOLOGICAL Golimumab 400 mg
- BIOLOGICAL Golimumab 50 mg
Study Locations (20)
Florida
- - Boca Raton
- - Gainesville
- - Hialeah
- - Naples
- - New Port Richey
- - Port Orange
- - Winter Park
- - Zephyrhills
California
- - Roseville
- - San Diego
Georgia
- - Atlanta
- - Savannah
Illinois
- - Arlington Heights
- - Chicago
Alabama
- - Birmingham
Arkansas
- - Little Rock
Colorado
- - Golden
Delaware
- - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,065 participants |
| Start Date | 2007-08 |
| Est. Completion | 2010-10 |
| Phase | Phase 2 |
What the finished NCT00487539 record still lists
NCT00487539 is an interventional study that assigns participants to a tested intervention. Its 1,065 participants enrollment target places it among the larger protocols in the corpus, above the 368-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (189% higher).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT00487539 names 20 study sites across 10 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT00487539 about?
NCT00487539 is a clinical study titled "An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with ulcerative colitis (UC).
What is the current status of trial NCT00487539?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,065 participants. The study started on 2007-08. Estimated completion is 2010-10.
What conditions does trial NCT00487539 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT00487539?
The interventions under investigation include: Placebo (BIOLOGICAL), Golimumab 100 mg (BIOLOGICAL), Golimumab 200 mg (BIOLOGICAL), Golimumab 400 mg (BIOLOGICAL), Golimumab 50 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00487539?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00487539 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00487539's enrollment target sits among peer trials
1,065 2nd of 28 the highest 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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