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

NCT00380796 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 88

Last updated 2013-09-04

No results posted yet for this 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.

Conditions

  • COPD
  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Collection of safety data for Cohort 1

Twice-yearly collection of information about cancer incidence and cause of death among patients who participated in clinical trials of infliximab in the treatment of COPD. The follow-up period is 5 years.

Sponsors & Collaborators

  • Centocor, Inc.

    lead INDUSTRY

Principal Investigators

  • Centocor, Inc. Clinical Trial · Centocor, Inc.

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2009-12-31
Completion
2009-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00380796 on ClinicalTrials.gov