Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00527072
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2007-09-06
Brief Title:
PSUNRISE - Prospective Study Using Remicade in Psoriasis Patients With an Inadequate Response to Etanercept
Sponsor:
Centocor Ortho Biotech Services LLC
Organization:
Centocor Ortho Biotech Services LLC
Study Overview
Official Title:
A Multicenter Open-label Study to Assess the Efficacy and Safety of Infliximab REMICADE Therapy in Patients With Plaque Psoriasis Who Had an Inadequate Response to Etanercept ENBREL
Status:
COMPLETED
Status Verified Date:
2012-08
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 test the safety and effectiveness of infliximab in patients with plaque psoriasis who have been receiving the drug etanercept for treatment of their plaque psoriasis for at least four months without enough improvement in their psoriasis symptoms
Detailed Description:
The most common form of psoriasis is plaque-type psoriasis which is characterized by recurrent flaring of thickened red scaly patches of skin Although psoriasis is usually not life threatening these physical discomforts combined with the potential psychological effects of the disease may interfere with everyday activities and negatively impact an individuals quality of life Many therapies are available for psoriasis however with limited effectiveness and significant toxicity Infliximab is an antibody made in a laboratory Antibodies are proteins that fight other substances in the body that may cause infections or diseases A substance called tumor necrosis factor TNF naturally occurs in the body TNF is related to the itchy patches of skin or plaques of psoriasis Infliximab stops the TNF from working Other studies have shown that stopping the TNF may reduce the plaques To address the unmet medical need for effective chronic therapies TNFalpha blockers have recently been used to treat patients with moderate to severe plaque psoriasis Etanercept also works by stopping the TNF but in a different way than infliximab This multi-center open-label study is designed to test whether or not patients with plaque psoriasis who have not responded well to etanercept treatment may benefit from treatment with infliximab Key effectiveness measurements will include the time to onset of symptom improvement and health-related quality of life Safety will be assessed throughout the study Two weeks after their last dose of etanercept all eligible patients will receive open-label 5 mgkg infliximab infusions at Weeks 0 2 6 14 and 22
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 |
|---|---|---|---|
| C0168Z04 | OTHER | Centocor Ortho Biotech Services LLC | None |