Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00488774 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
A Phase 2 study, sponsored by Janssen Research & Development.
- Terminated
- Registry status
- Phase 2
- Development phase
- 291
- Enrollment target
NCT00488774: Clinical Trial Phase 2 study, sponsored by Janssen Research & Development.
NCT00488774 is a Phase 2 study that was terminated before completion, run by Janssen Research & Development. The registered enrollment target is 291 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (119% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488774, a Phase 2 study, was terminated before completion, sponsored by Janssen Research & Development.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 291 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
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 a physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease
Interventions
- OTHER Placebo
- DRUG Golimumab 1 mg per kg
- DRUG Golimumab 2 mg per kg
- DRUG Golimumab 4 mg per kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 291 participants |
| Start Date | 2007-08 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
Why NCT00488774 stopped before completion
NCT00488774 is an interventional study that assigns participants to a tested intervention. The registered 291 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (119% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00488774 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488774 about?
NCT00488774 is a clinical study titled "An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis". The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
What is the current status of trial NCT00488774?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 291 participants. The study started on 2007-08. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00488774?
The interventions under investigation include: Placebo (OTHER), Golimumab 1 mg per kg (DRUG), Golimumab 2 mg per kg (DRUG), Golimumab 4 mg per kg (DRUG).
Who is sponsoring clinical trial NCT00488774?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00488774's enrollment target sits among peer trials
291 191st of 2000 higher than 1,810 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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
- NCT02074839 · 291 participants · Phase 1
Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation
- NCT03769766 · 291 participants · Phase 3
Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
- NCT06563479 · 291 participants · Phase 3
A Study Comparing Personalized Radiation Therapy With Standard Radiation Therapy in People With HPV-Positive Throat Cancer
- NCT04429542 · 292 participants · Phase 1
Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
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