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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 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.

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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).

Conditions Studied

Colitis, Ulcerative

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

FieldValue
Enrollment Target 1,065 participants
Start Date 2007-08
Est. Completion 2010-10
Phase Phase 2

Sponsor

Janssen Research & Development

593 total trials

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What the Registry Record Tells You About NCT00487539

The ClinicalTrials.gov registry entry for NCT00487539 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 1,065 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 368-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (189% higher). 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 5 interventions - of which Placebo is the first listed.

NCT00487539 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.