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COMPLETED Phase 2

An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis

NCT00487539 · View on ClinicalTrials.gov ↗

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

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

442 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00487539

The ClinicalTrials.gov registry entry for NCT00487539 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,065 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00487539 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00487539?

This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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