Know Cancer

forgot password

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

Phase 0
18 Years
80 Years
Open (Enrolling)
Inclusion Body Myositis

Thank you

Trial Information

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

Travel expenses not covered by the study.

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.

Exclusion Criteria:

- Exposure to etanercept within 3 months of study entry

- Exposure to other investigational drugs within 3 months of study entry.

- Subject with known hypersensitivity to etanercept.

- Subject with active medical or psychiatric condition that in the opinion of the
principal investigator, may affect the interpretation of the safety and efficacy data
or which otherwise contraindicates participation in the study.

- Signs, symptoms or laboratory evidence of severe renal, pulmonary, hepatic,
neurologic, or cardiac (congestive heart failure, or coronary artery) disease,
including creatinine > 2.0, LFT > 2x the upper limit of normal and hemoglobin < 12.5
(male) and < 11.0 (female).

- Subject with weakness from any other neurological or neuromuscular disease, including
multiple sclerosis or other CNS demyelinating disease.

- Subject with sepsis or any active, chronic, or local infection or on antibiotic,
antiviral or antifungal medication within 3 months prior to the first dose of

- A prior history of tuberculosis and/or a positive PPD skin test at screening
(including reading of borderline, reactive but non-diagnostic) or prior inoculated

- Human immunodeficiency virus infection.

- Subject with history of opportunistic infection.

- Subject with a known history of anti-Jo-1, anti-SRP or anti-MI-2 antibodies.

- The presence of an associated connective tissue disease, including systemic lupus
erythematous, Sjögren's syndrome, scleroderma or mixed connective tissue disease.

- History of a new diagnosis or treatment of invasive malignancy within 5 years of
enrollment, including patients with a history of squamous cell carcinoma or basal
cell carcinoma.

- History of drug or alcohol abuse within 1 year prior to study entry.

- Unwillingness to practice effective contraception, except for female patients who are
post-menopausal or surgically sterile. The rhythm method is not to be used as the
sloe method of contraception.

- Subjects are not to receive live vaccines while in the study.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in Quantitative Muscle Testing on 12 proximal and 12 distal muscles

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Glenn Lopate, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Institutional Review Board

Study ID:




Start Date:

April 2005

Completion Date:

Related Keywords:

  • Inclusion Body Myositis
  • Myositis
  • Myositis, Inclusion Body



Washington University Department of Neurology Saint Louis, Missouri  63110