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NCT00802815 · ClinicalTrials.gov registry record · Early Phase 1
Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis
A Early Phase 1 study of Inclusion Body Myositis, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT00802815 is a Early Phase 1 study of Inclusion Body Myositis that has completed, run by Washington University School of Medicine. The registered enrollment target is 20 participants, below the 234-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00802815, a Early Phase 1 study of Inclusion Body Myositis, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients develop progressive weakness that may result in the need for assistive devices including a wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of tumor necrosis factor (TNF)-alpha. Etanercept blocks the activity of TNF-alpha, thereby blunting immune overactivation. Previous unblinded studies and case reports suggest that etanercept may improve strength or slow the progressive weakness in IBM. We are conducting a double-blind, randomized, placebo-controlled study to test if Etanercept is beneficial in slowing the progressive weakness in patients with IBM.
Conditions Studied
Interventions
- DRUG Etanercept
Study Locations (1)
Missouri
- Washington University Department of Neurology - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2005-04 |
| Est. Completion | 2014-05 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00802815
The ClinicalTrials.gov registry entry for NCT00802815 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 234-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (91% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Inclusion Body Myositis appearing as the primary indexed condition, and to 1 intervention - of which Etanercept is the first listed.
NCT00802815 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT00802815 about?
NCT00802815 is a clinical study titled "Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis". Inclusion body myositis (IBM) is the most common late onset acquired muscle disease. Patients develop progressive weakness that may result in the need for assistive devices including a wheelchair. IBM may be due to abnormal immune activation, due in part to overproduction of tumor necrosis factor (T...
What is the current status of trial NCT00802815?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2005-04. Estimated completion is 2014-05.
What conditions does trial NCT00802815 study?
This clinical trial studies the following conditions: Inclusion Body Myositis.
What interventions are being tested in trial NCT00802815?
The interventions under investigation include: Etanercept (DRUG).
Who is sponsoring clinical trial NCT00802815?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00802815 being conducted?
This trial has 1 study location across Missouri. 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
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