Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00036439
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2002-05-10
Brief Title:
A Safety and Efficacy Study for Infliximab Remicade in Patients With Active Ulcerative Colitis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Randomized Placebo-controlled Double-blind Trial to Evaluate the Safety and Efficacy of Infliximab in Patients With Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2010-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 the effectiveness and safety of infliximab Remicade in patients with Ulcerative Colitis
Detailed Description:
This is a study designed to investigate the safety and effectiveness of a medication called infliximab the active drug in REMICADE in adult patients with active ulcerative colitis The purpose of this study is to see if the symptoms of ulcerative colitis are lessened with this medication infliximab and what dose is needed to do that safely Patients will receive infusions of either 5mgkg 10 mgkg or placebo at weeks 0 2 6 and then once every 8 weeks thereafter through week 46 for up to 3 years
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive infusions of either 5mgkg 10 mgkg or placebo at weeks 0 2 6 and then once every 8 weeks thereafter through week 46 for up to 3 years
Safety evaluations will be performed at specified intervals throughout the study and will consist of laboratory tests vital signs such as blood pressure physical examinations and the occurrence and severity of adverse events as well as other study specific procedures Patients will receive infusions of either 5mgkg 10 mgkg or placebo at weeks 0 2 6 and then once every 8 weeks thereafter through week 46 for up to 3 years
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