Ignite Creation Date:
2024-05-05 @ 5:05 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380796
Status:
COMPLETED
Last Update Posted:
2013-09-04
First Post:
2006-09-22
Brief Title:
A Long-term Safety Study of Infliximab in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease COPD
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 patients last safety visit in the primary study
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 in the US 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 patients 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 patients 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 AEss are recorded in the primary studyTwice 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-rayposterior 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 patients subsequent visit data will be collected by either direct contact with the patient office visit or telephone call review of patients medical records contact with the patients primary care physician or oncologist At the final visit 5 years from each patients 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 Hodgkins lymphoma non-Hodgkins lymphoma head and neck cancers lung cancer other malignancies No drug is provided
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 Hodgkins lymphoma non-Hodgkins lymphoma head and neck cancers lung cancer other malignancies No drug is provided
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| C0168T70 | OTHER | Centocor | None |