Ignite Creation Date:
2024-05-05 @ 11:59 AM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00207688
Status:
COMPLETED
Last Update Posted:
2018-07-06
First Post:
2005-09-13
Brief Title:
A Long Term Safety Study of Infliximab Remicade in in Ulcerative Colitis Patients
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Multicenter International Study of the Long-term Safety of Infliximab REMICADE in Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2018-07
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 study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis
Detailed Description:
This is a long term multicenter international safety study to evaluate targeted long-term safety information on patients who have participated in infliximabRemicade clinical studies in ulcerative colitis that require long-term safety follow-up All patients who received at least one dose of study drug infliximab or placebo in the primary studies C0168T37 C0168T46 C0168T72 are eligible to participate in this long-term safety follow-up study C0168T62 Patients will begin participation in C0168T62 at the time of their last safety visit in the primary study and will be followed for 5 years No study agent will be administered Information on deaths serious infections new malignancies including colorectal cancer and new autoimmune diseases and surgical procedures including colectomy and hospitalizations for the treatment of ulcerative colitis will be collected Information about possible delayed allergic reactions possible fever rash fatigue joint pain will also be collected if patients received infliximab after the end of the primary study In addition data on dysplasia of the colon will be collected from patients who were identified in the primary study to be at high-risk for colon cancer and were required per protocol to undergo a follow-up colonoscopy as part of long-term safety follow-up All adverse events including non-serious adverse events will also be collected
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| C0168T62 | OTHER | Janssen Research Development LLC | None |