Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies
Status:
Completed
Trial end date:
2002-07-01
Target enrollment:
Participant gender:
Summary
Inflammatory myopathies are a group of muscle diseases characterized by muscle weakness, high
levels of muscle enzymes in the blood, and inflammation of the tissue surrounding muscle
fibers (endomysium).
The diseases making up the inflammatory myopathies are grouped into three subsets:
I) Polymyositis (PM)
II) Dermatomyositis (DM)
III) Inclusion Body Myositis (IBM)
Inflammatory myopathies are thought to be autoimmune processes and are treated with steroids
and immunosuppressive drugs. However, many patients who initially respond to these treatments
develop resistance to the therapy or experience side effects causing the treatments to be
stopped.
Researchers believe that intravenous immunoglobulin (IVIg) may provide patients with PM, DM,
and IBM a safer and more effective alternative to standard therapies for the diseases. IVIg
is a drug that has been used successfully to treat other immune-related diseases of the
nervous system.
The study will take 60 patients and divide them into two groups. Group one will receive 2
injections of IVIg once a month for three months. Group two will receive 2 injections of
placebo "inactive injection of sterile water" once a month for three months. Following the
three months of treatment, group one will begin taking the placebo and group two will begin
taking IVIg for an additional 3 months. The drug will be considered effective if patients
receiving it experience a significant improvement (>15%) in muscle strength.
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)