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Sponsors and Collaborators: |
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) FDA Office of Orphan Products Development |
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Information provided by: | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) |
ClinicalTrials.gov Identifier: | NCT00005007 |
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.
Condition | Intervention | Phase |
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Wegener's Granulomatosis |
Drug: Etanercept |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Wegener's Granulomatosis Etanercept Trial (WGET) |
Estimated Enrollment: | 181 |
Study Start Date: | June 2000 |
Study Completion Date: | March 2003 |
Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | 11 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21224 | |
United States, Massachusetts | |
Boston University | |
Boston, Massachusetts, United States, 02118 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48109 | |
United States, Minnesota | |
Mayo Clinic | |
Rochester, Minnesota, United States, 55905 | |
United States, New York | |
Beth Israel Medical Center | |
New York, New York, United States, 10128 | |
United States, North Carolina | |
Duke University | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 |
Principal Investigator: | John H. Stone, MD, MPH | Johns Hopkins University |
Responsible Party: | Massachusetts General Hospital ( John H. Stone, M.D., M.P.H. ) |
Study ID Numbers: | N01 AR92240, NIAMS-041 |
Study First Received: | March 24, 2000 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00005007 |
Health Authority: | United States: Food and Drug Administration |
Wegener's granulomatosis Vasculitis Etanercept Tumor necrosis factor |
Lung Diseases, Interstitial Necrosis Vasculitis Urologic Diseases Respiratory Tract Diseases Wegener Granulomatosis |
Lung Diseases Wegener's granulomatosis Vascular Diseases Kidney Diseases TNFR-Fc fusion protein |
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic Sensory System Agents |
Therapeutic Uses Cardiovascular Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |