Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Completed Early Phase 1 study of Inclusion Body Myositis, sponsored by Washington University School of Medicine.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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

FieldValue
Enrollment Target 20 participants
Start Date 2005-04
Est. Completion 2014-05
Phase Early Phase 1

What the finished NCT00802815 record still lists

NCT00802815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 234-participant average among 10 other Inclusion Body Myositis trials with a reported enrollment target (91% lower).

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 a single indexed study location in 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.

Similar trials for Inclusion Body Myositis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00802815's enrollment target sits among peer trials

20 7th of 10 higher than 2 of 10 other Inclusion Body Myositis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Inclusion Body Myositis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00573339 · 20 participants

    Cardiac Magnetic Resonance Imaging (MRI) Normal Reference Control Group Testing

  • NCT00692939 · 20 participants · Phase 1

    Autologous Stem Cell Transplantation for Crohn's Disease

  • NCT00967785 · 20 participants · Phase 1

    A Phase I Study of Mozobil in the Treatment of Patients With WHIMS

  • NCT01406691 · 20 participants · Phase 4

    Light Flashes to Treat Delayed Sleep Phase Disorder (DSPD)

Similar registry start date

  • NCT05988463 · started 2027-01-01 · Phase 1

    Dose-Escalation Study of Artesunate Patients With IPF

  • NCT07219706 · started 2026-12-10 · NA

    Dietary Fiber and Time Restricted Eating

  • NCT02831335 · started 2026-12-01

    Technical Development of Multi-Parametric Renocerebral MRI

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

Source: ClinicalTrials.gov NCT00802815, the US trial registry maintained by the National Library of Medicine. NCT00802815 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.