Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00261976
Status:
COMPLETED
Last Update Posted:
2014-03-18
First Post:
2005-12-02
Brief Title:
A Long-term Safety Study of Infliximab Remicade
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
Long-term Safety Follow-up of REMICADE RESULTS
Status:
COMPLETED
Status Verified Date:
2014-03
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:
This is a study evaluating the long-term safety of infliximab Remicade
Detailed Description:
The purpose of this study is to collect long-term safety information on infliximab Remicade from patients who participate in research studies using those drugs All patients in these 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 survival serious infections new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period Additional information about possible delayed allergic reactions possible fever rash fatigue joint pain will also be collected if you received infliximab Remicade after the end of the primary study Study participation in this research study is 5 years after the end of the primary study Questionnaires will be completed about patients health and the occurrence of these safety events at intervals of 6 months 1 year 2 years 3 years 4 years and 5 years after patients complete participation in the primary study
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 |
|---|---|---|---|
| C0168T45 | OTHER | Centocor Inc | None |