Polymyositis, dermatomyositis and inclusion-body myositis.
M C Dalakas
https://pubmed.ncbi.nlm.nih.gov/1658649Completed
Phase 2
All Genders
ID00001261
The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2008-03-04
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies
Who Can Participate
All Genders
Eligibility Criteria
You may qualify if you...
INCLUSION CRITERIA:
Selected patients should have PM, IBM or DM.
Specifically they should have a) proximal muscle weakness; b) no evidence of clinical, histological or family history of another neuromuscular illness; c) elevation of muscle enzymes during the course of the disease; d) typical skin rash in case of DM; and e) diagnostic muscle biopsy.
Suitable candidates for IVIg should be patients with active, bonefide disease who:
- have been treated with steroids but had: a) no response or incomplete response (as defined by continued muscle weakness) to high-dose therapy or b) a good response to steroids but inability to taper the dose without a flare of disease activity or c) unacceptable steroid side effects such as gastrointestinal hemorrhages, osteonecrosis, hyperglycemia, extreme weight gain etc., and
- have been treated with one immunosuppressive drug (such as azathioprine, Methotrexate, Cyclophosphamide, Cyclosporine) but without benefit or with unacceptable side effects.
EXCLUSION CRITERIA:
Pregnant or nursing women (confirmed by a screening pregnancy test).
Critically ill patients such as those requiring intravenous pressors for maintenance of cardiac output due to severe cardiomyopathy, patients with respiratory insufficiency and patients with severe muscle weakness requiring help for basic self care.
Children below age 18.
Patients with severe renal or hepatic disease, severe COPD or coronary artery disease or other systemic medical problems often seen when PM or DM is associated with severe cases of lupus, rheumatoid arthritis or scleroderma.
Patients with known allergic reaction to IVIg.
Serum IgA less than 11mg/dl.
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
Trial Site Locations
Total: 1 location
1
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States, 20892
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Treatment of polymyositis and dermatomyositis.
M Dalakas
https://pubmed.ncbi.nlm.nih.gov/2702045Reversal of chronic polymyositis following intravenous immune serum globulin therapy.
C M Roifman, F M Schaffer, S E Wachsmuth...
https://pubmed.ncbi.nlm.nih.gov/3599350