Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106834
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-03-31
Brief Title:
A Study of the Safety and Efficacy of Infliximab in Patients With Psoriasis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase 3 Multi-Center Randomized Double-Blind Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction and Maintenance Therapy in Patients With Moderate to Severe Plaque Psoriasis
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 determine if infliximab anti-TNF is effective in the treatment of plaque psoriasis
Detailed Description:
This is an experimental medical research study The purpose of this study is to determine if infliximab is effective in the treatment of plaque psoriasis A total of about 375 patients primarily in Europe will participate in this study The time of participation in this study is about 17 months Infliximab is the active drug in Remicade Infliximab is currently approved for the treatment of Crohns disease an irritable bowel disease and rheumatoid arthritis The usefulness and safety of infliximab in those diseases has been proven in previous research studies which included more than 1300 patients in North America and Europe In a previous small study of infliximab in 33 patients with psoriasis about 80 of patients treated with infliximab showed improvement in their psoriasis symptoms after the first 3 infusions while 20 of patients who received placebo showed improvement
Patients will be assigned to one of two treatment groups Group 1 and Group 2 Group 1 will receive 5mgkg infliximab infusions at wks 0 2 4 6 14 22 30 38 and 46 with placebo infusions at wks 24 and 26 Group 2 will receive placebo infusions at wks 0 2 6 10 14 22 with placebo infusions at wks 24 26 30 38 and 46 All study medication is given though an intravenous into the vein line
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 There are 2 different treatment groups Group 1 will receive 5mgkg infliximab infusions at wks 0 2 4 6 14 22 30 38 and 46 with placebo infusions at wks 24 and 26 Group 2 will receive placebo infusions at wks 0 2 6 10 14 22 with placebo infusions at wks 24 26 30 38 and 46 All study medication is given though an intravenous into the vein line
Patients will be assigned to one of two treatment groups Group 1 and Group 2 Group 1 will receive 5mgkg infliximab infusions at wks 0 2 4 6 14 22 30 38 and 46 with placebo infusions at wks 24 and 26 Group 2 will receive placebo infusions at wks 0 2 6 10 14 22 with placebo infusions at wks 24 26 30 38 and 46 All study medication is given though an intravenous into the vein line
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 There are 2 different treatment groups Group 1 will receive 5mgkg infliximab infusions at wks 0 2 4 6 14 22 30 38 and 46 with placebo infusions at wks 24 and 26 Group 2 will receive placebo infusions at wks 0 2 6 10 14 22 with placebo infusions at wks 24 26 30 38 and 46 All study medication is given though an intravenous into the vein line
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