Wegener's Granulomatosis Clinical Trial
Official title:
Wegener's Granulomatosis Etanercept Trial (WGET)
This study will determine if the drug etanercept, also called Enbrel, is effective in
producing and maintaining remission (reduction of disease symptoms) of Wegener's
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.
The Wegener's 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 Wegener's 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 II/III 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 1:1. 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 (i.e., 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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