Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106847
Status:
COMPLETED
Last Update Posted:
2011-05-17
First Post:
2005-03-31
Brief Title:
A Study of the Safety and Effectiveness of Infliximab in Patients With Plaque-type Psoriasis
Sponsor:
Centocor Inc
Organization:
Centocor Inc
Study Overview
Official Title:
A Phase III Multicenter Randomized Double-Blind Placebo-Controlled Trial Evaluating the Efficacy and Safety of Infliximab Induction Therapy Followed by Multiple Regimens of Maintenance InfliximabTherapy in Patients With Plaque-Type Psoriasis
Status:
COMPLETED
Status Verified Date:
2010-04
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 the study is to evaluate the safety and effectiveness of scheduled and as needed treatment of psoriasis with infliximab Infliximab Remicade targets specific proteins in the bodys immune system to help control the development of inflammation to help reduce painful disease
Detailed Description:
This is a phase III multicenter randomized patients are assigned different treatments based on chance double-blind neither the patient nor the physician knows whether drug or placebo is being taken or at what dosage placebo-controlled trial evaluating the effectiveness and safety of scheduled and as needed treatment with infliximab in patients with plaque-type psoriasis This study will also help determine the way to use infliximab in treating patients with psoriasis
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 placebo 3mgkg or 5 mgkg infliximab Remicade at weeks 0 2 6 14 18 22 26 30 34 38 42 and 46 Patients receive either 3mgkg 5 mgkg or placebo infusions at week 0 2 and 6 The 3mgkg and 5 mgkg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75 improved from baseline The placebo patients begin infliximab at week 16 18 and 22 followed by every 8 week infusions
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 placebo 3mgkg or 5 mgkg infliximab Remicade at weeks 0 2 6 14 18 22 26 30 34 38 42 and 46 Patients receive either 3mgkg 5 mgkg or placebo infusions at week 0 2 and 6 The 3mgkg and 5 mgkg infliximab groups then receive either every 8 week infusions or infusions as needed when their psoriasis is less than 75 improved from baseline The placebo patients begin infliximab at week 16 18 and 22 followed by every 8 week infusions
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