NCT00802815

Double-blind, Randomized, Placebo-controlled Trial of Etanercept for 12 Months in Subjects With Inclusion Body Myositis

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Travel expenses not covered by the study.

Conditions

• Inclusion Body Myositis

Interventions

Type	Name	Description
DRUG	Etanercept	50 milligrams subcutaneously every week

Timeline

• Start date: 2005-04-01
• Primary completion: 2014-05-01
• Completion: 2014-05-01
• First posted: 2008-12-05
• Last updated: 2014-05-29

Locations

1 site across 1 country: United States