Inclusion Body Myositis
Conditions
Brief 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.
Interventions
DRUGEtanercept
50 milligrams subcutaneously every week
Sponsors
Amgen
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* A clinical diagnosis of definite or probable IBM. * Male or female aged 18-80. * Subjects must be able to provide informed consent. * Subjects must be on no immunosuppressive medication for 3 months and agree not to take immunosuppressive medication during the study. * Subjects must not be on sulfasalazine * Subjects or caregivers must be able to administer SQ medication. * Women of childbearing potential (not postmenopausal or surgically sterile) must have a negative pregnancy test at screening and be using adequate birth control. * Absence of
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles | 12 months |
Countries
United States
Outcome results
None listed