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NCT00488631 · ClinicalTrials.gov registry record · Phase 3
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,228
- Enrollment target
NCT00488631: Completed Phase 3 study, sponsored by Janssen Research & Development.
NCT00488631 is a Phase 3 study that has completed, run by Janssen Research & Development. The registered enrollment target is 1,228 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00488631, a Phase 3 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,228 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
Primary Outcome
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL Golimumab 100 mg
- BIOLOGICAL Golimumab 200 mg
- BIOLOGICAL Golimumab 50 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,228 participants |
| Start Date | 2007-09 |
| Est. Completion | 2015-02 |
| Phase | Phase 3 |
What the finished NCT00488631 record still lists
NCT00488631 is an interventional study that assigns participants to a tested intervention. Its 1,228 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (59% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT00488631 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00488631 about?
NCT00488631 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 safety and efficacy of golimumab administered subcutaneously (under the skin) injections in maintenance therapy.
What is the current status of trial NCT00488631?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,228 participants. The study started on 2007-09. Estimated completion is 2015-02.
What interventions are being tested in trial NCT00488631?
The interventions under investigation include: Placebo (BIOLOGICAL), Golimumab 100 mg (BIOLOGICAL), Golimumab 200 mg (BIOLOGICAL), Golimumab 50 mg (BIOLOGICAL).
Who is sponsoring clinical trial NCT00488631?
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 NCT00488631's enrollment target sits among peer trials
1,228 214th of 2000 higher than 1,787 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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