Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00001261
• Date of registration: 03/11/1999
• Prospective Registration: No
• Primary sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
• Public title: Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies
• Scientific title: The Efficacy of High-Dose Intravenous Immunoglobulin in Patients With Inflammatory Myopathies: A Three Month Randomized Trial With Option for Cross-Over
• Date of first enrolment: May 1990
• Target sample size: 120
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00001261
• Study type: Interventional
• Study design: Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Key inclusion & exclusion criteria

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:

1. 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

2. 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.



Age minimum: N/A
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Inclusion Body Myositis

Dermatomyositis

Polymyositis

Intervention(s)

Drug: Gamma Globulin

Secondary ID(s)

90-N-0139

900139

Source(s) of Monetary Support

Please refer to primary and secondary sponsors