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COMPLETED

A Long-term Safety Study of Infliximab in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).

NCT00380796 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this long-term observational study is designed to collect additional information on incidence of cancer and cause of death among patients who have participated in clinical trials of infliximab in the treatment of COPD. Patients must have received at least 1 dose of study agent (ie, placebo or infliximab) in the primary studies to be eligible for participation in this long-term follow-up study. Information on deaths and cancers will be collected twice yearly for a period of 5 years from each patient's last safety visit in the primary study.

Interventions

  • DRUG Collection of safety data for Cohort 1

Study Locations (20)

Pennsylvania

  • — Easton
  • — Hershey
  • — Philadelphia

California

  • — Anaheim
  • — San Diego

Florida

  • — Bay Pines
  • — Clearwater

Missouri

  • — Saint Charles
  • — St Louis

New York

  • — Endwell
  • — Larchmont

Georgia

  • — Blue Ridge

Maryland

  • — Baltimore

Massachusetts

  • — Springfield

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2006-04
Est. Completion 2009-12

Sponsor

Centocor

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00380796

The ClinicalTrials.gov registry entry for NCT00380796 describes a study currently listed as completed. It is categorized as an unspecified phase, 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 88 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centocor, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with COPD appearing as the primary indexed condition, and to 1 intervention — of which Collection of safety data for Cohort 1 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: NCT00380796 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Pennsylvania, California, Florida. 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 NCT00380796 about?

NCT00380796 is a clinical study titled "A Long-term Safety Study of Infliximab in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).". The purpose of this long-term observational study is designed to collect additional information on incidence of cancer and cause of death among patients who have participated in clinical trials of infliximab in the treatment of COPD. Patients must have received at least 1 dose of study agent (ie, pl...

What is the current status of trial NCT00380796?

This trial is currently completed. The enrollment target is 88 participants. The study started on 2006-04. Estimated completion is 2009-12.

What conditions does trial NCT00380796 study?

This clinical trial studies the following conditions: COPD, Pulmonary Disease, Chronic Obstructive. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00380796?

The interventions under investigation include: Collection of safety data for Cohort 1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00380796?

This trial is sponsored by Centocor, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT00380796 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Maryland, Massachusetts. 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