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NCT00005007 · ClinicalTrials.gov registry record · Phase 2
Etanercept for Wegener's Granulomatosis
A Phase 2 study of Wegener's Granulomatosis, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- Completed
- Registry status
- Phase 2
- Development phase
- 181
- Enrollment target
- 8
- Study locations
NCT00005007 is a Phase 2 study of Wegener's Granulomatosis that has completed, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The registered enrollment target is 181 participants, above the 49-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target (269% higher). The trial reports 8 study locations across 8 states.
The verdict
NCT00005007, a Phase 2 study of Wegener's Granulomatosis, has completed, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 181 participants
- Enrollment target
- 8
- Study locations
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 Studied
Interventions
- DRUG Etanercept
Study Locations (8)
California
- University of California, San Francisco - San Francisco
Maryland
- Johns Hopkins University - Baltimore
Massachusetts
- Boston University - Boston
Michigan
- University of Michigan - Ann Arbor
Minnesota
- Mayo Clinic - Rochester
New York
- Beth Israel Medical Center - New York
North Carolina
- Duke University - Durham
Ohio
- Cleveland Clinic Foundation - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 181 participants |
| Start Date | 2000-06 |
| Est. Completion | 2003-03 |
| Phase | Phase 2 |
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)93 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00005007
The ClinicalTrials.gov registry entry for NCT00005007 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 181 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 49-participant average among 7 other Wegener's Granulomatosis trials with a reported enrollment target (269% higher). The listed sponsor is National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Wegener's Granulomatosis appearing as the primary indexed condition, and to 1 intervention - of which Etanercept is the first listed.
NCT00005007 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Maryland, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00005007 about?
NCT00005007 is a clinical study titled "Etanercept for Wegener's Granulomatosis". 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 co...
What is the current status of trial NCT00005007?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 181 participants. The study started on 2000-06. Estimated completion is 2003-03.
What conditions does trial NCT00005007 study?
This clinical trial studies the following conditions: Wegener's Granulomatosis.
What interventions are being tested in trial NCT00005007?
The interventions under investigation include: Etanercept (DRUG).
Who is sponsoring clinical trial NCT00005007?
This trial is sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), which has 93 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00005007 being conducted?
This trial has 8 study locations across California, Maryland, Massachusetts, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.