Status:
COMPLETED
A Long-term Safety Study of Infliximab in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
Lead Sponsor:
Centocor, Inc.
Conditions:
COPD
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
Brief 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 inf...
Detailed Description
This study is designed to collect long-term safety information on infliximab, from patients with COPD who participated in research studies using this drug. The primary COPD studies include C0168T54 (i...
Eligibility Criteria
Inclusion
- Patients must have been enrolled in previously completed clinical studies of infliximab in the treatment of COPD that are targeted for long term safety follow-up (ie, primary studies). Primary studies are defined as studies that have evaluated infliximab on an investigational basis and that have been identified by Centocor or health authorities as requiring long-term safety follow-up. These include Centocor protocol C0168T54, conducted in the USA, and 2 smaller studies conducted in the Netherlands (EU0016 C0168X09 and EU0073 C0168X57). Patients must have received at least one dose of study agent to be eligible.
Exclusion
- Patients who are unwilling to respond to requests for long-term safety information will be excluded.
Key Trial Info
Start Date :
April 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT00380796
Start Date
April 1 2006
End Date
December 1 2009
Last Update
September 4 2013
Active Locations (26)
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1
Anaheim, California, United States
2
San Diego, California, United States
3
Bay Pines, Florida, United States
4
Clearwater, Florida, United States