A Multicenter, Observational Study of the Long-term Safety of Infliximab (REMICADE) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). RESULTS COPD: REMICADE Safety Under Long Term Study in COPD

Trial Information

A Multicenter, Observational Study of the Long-term Safety of Infliximab (REMICADE) in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD). RESULTS COPD: REMICADE Safety Under Long Term Study in COPD

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 (in the U.S.) and two small studies in Europe (EU0016 C0168X09 and EU0073
C0168X57). All patients who had at least one dose of study drug in those studies are being
asked to participate in this long-term safety follow-up study which will provide important
information about the study drug. The long-term effect of the study drug on new cancers and
survival will be evaluated from data collected over a 5-year period which begins from each
patient's last safety visit in the primary study. Data for this study will be collected at
study entry and twice yearly thereafter up to a maximum of 5 years from each patient's last
safety visit in the primary study. The last safety visit in the primary study is defined as
the last visit for each subject during which adverse events (AEs)s are recorded in the
primary study.Twice yearly, all participating study sites will be reminded to complete the
electronic charts for each participating patient. At study entry, the following will be
performed: (1) Medical history and physical examination, including ear, nose, and throat
(ENT) examination performed by a qualified physician; (2) Chest x-ray(posterior and
lateral), unless performed within 3 months prior to enrollment and (3) CT (computer imaging)
scan of the chest (spiral preferred), unless performed within 6 months prior to enrollment.
In addition, data will be collected at study entry on the use of commercial infliximab or
any other anti-tumor necrosis factor (anti-TNF) agent subsequent to the last safety visit in
the primary study. At each patient's subsequent visit, data will be collected by either
direct contact with the patient (office visit or telephone call), review of patient's
medical records, contact with the patient's primary care physician or oncologist. At the
final visit (5 years from each patient's last safety visit in the primary study), the
following will be performed: (1) Medical history and physical examination, including ENT
examination performed by a qualified physician; (2) Chest x-ray, unless performed within the
previous 3 months, and (3) CT scan of the chest (spiral preferred), unless performed within
the previous 6 months.

The primary outcome of this study is Number of patients with each of the following safety
events: malignancy or death. The secondary outcome of this study is the number of patients
with malignancies by malignancy type (ie, Hodgkin's lymphoma, non-Hodgkin's lymphoma, head
and neck cancers, lung cancer, other malignancies). No drug is provided