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Etanercept for Wegener's Granulomatosis

NCT00005007 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 181

Last updated 2007-12-28

No results posted yet for this study

Summary

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.

Conditions

  • Wegener's Granulomatosis

Interventions

DRUG

Etanercept

Sponsors & Collaborators

  • FDA Office of Orphan Products Development

    collaborator FED

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    lead NIH

Principal Investigators

  • John H. Stone, MD, MPH · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2003-03-31
Completion
2003-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00005007 on ClinicalTrials.gov