Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005007
Status:
COMPLETED
Last Update Posted:
2007-12-28
First Post:
2000-03-24
Brief Title:
Etanercept for Wegeners Granulomatosis
Sponsor:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Organization:
National Institute of Arthritis and Musculoskeletal and Skin Diseases NIAMS
Study Overview
Official Title:
Wegeners Granulomatosis Etanercept Trial WGET
Status:
COMPLETED
Status Verified Date:
2007-12
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:
This study will determine if the drug etanercept also called Enbrel is effective in producing and maintaining remission reduction of disease symptoms of Wegeners granulomatosis WG Etanercept blocks the action of tumor necrosis factor-alpha a substance that may be involved in inflammatory conditions such as WG Eight clinical centers around the United States will enroll 181 people who have WG Patients will have an equal chance to receive either etanercept or placebo inactive treatment We will treat patients with standard medications for WG in addition to either etanercept or placebo We will treat all patients with tapering doses of corticosteroids
After the patients disease is controlled in remission we will reduce the dosages of the standard medications to lower the risk of side effects associated with these drugs During the study we will collect and save blood and tissues samples from patients and use the samples to address other medical questions such as the cause of WG and factors that lead to disease progression
After the patients disease is controlled in remission we will reduce the dosages of the standard medications to lower the risk of side effects associated with these drugs During the study we will collect and save blood and tissues samples from patients and use the samples to address other medical questions such as the cause of WG and factors that lead to disease progression
Detailed Description:
The Wegeners Granulomatosis Etanercept Trial WGET is a randomized placebo-controlled clinical trial A primary objective of the trial is to evaluate the safety and efficacy of etanercept Enbrel Immunex Corporation Seattle WA for the induction and maintenance of disease remissions for people with Wegeners granulomatosis WG when used in conjunction with standard medications A secondary objective is to develop a specimen bank of serum plasma whole blood and tissue biopsy samples that may be used to address basic questions regarding the etiology pathophysiology and monitoring of WG
The trial is a phase IIIII randomized double-masked multicenter trial with a parallel treatment design We will assign patients randomly to either etanercept or placebo in an assignment ratio of 11 In addition to either etanercept or placebo we will treat all patients with standard drug regimens for WG according to the severity of their disease We will treat those with limited WG with methotrexate and corticosteroids and those with severe WG with cyclophosphamide and corticosteroids After the patients disease is controlled with therapy ie the standard treatment regimen plus either etanercept or placebo we will taper the standard medications according to regimens designed to ensure patient safety diminish morbidity associated with the standard medications and test the efficacy of etanercept in sustaining disease remissions
The principal outcome measure in this trial is the number of patients in the two treatment arms who achieve sustained remissions measured by the Birmingham Vasculitis Activity Score for WG BVAS The sample size is 181 patients recruited at eight clinical centers in the United States We will stratify randomization by clinic and disease severity limited versus severe Every patient enrolled will have a BVAS of at least three insuring unequivocally active disease
We will follow all randomized patients regardless of whether or not they remain on their assigned treatments until the common closing date of the trial defined as 12 months after enrollment of the last patient We will perform the primary analyses on an intention-to-treat basis
The trial is a phase IIIII randomized double-masked multicenter trial with a parallel treatment design We will assign patients randomly to either etanercept or placebo in an assignment ratio of 11 In addition to either etanercept or placebo we will treat all patients with standard drug regimens for WG according to the severity of their disease We will treat those with limited WG with methotrexate and corticosteroids and those with severe WG with cyclophosphamide and corticosteroids After the patients disease is controlled with therapy ie the standard treatment regimen plus either etanercept or placebo we will taper the standard medications according to regimens designed to ensure patient safety diminish morbidity associated with the standard medications and test the efficacy of etanercept in sustaining disease remissions
The principal outcome measure in this trial is the number of patients in the two treatment arms who achieve sustained remissions measured by the Birmingham Vasculitis Activity Score for WG BVAS The sample size is 181 patients recruited at eight clinical centers in the United States We will stratify randomization by clinic and disease severity limited versus severe Every patient enrolled will have a BVAS of at least three insuring unequivocally active disease
We will follow all randomized patients regardless of whether or not they remain on their assigned treatments until the common closing date of the trial defined as 12 months after enrollment of the last patient We will perform the primary analyses on an intention-to-treat basis
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 |
|---|---|---|---|
| NIAMS-041 | None | None | None |