Status:

COMPLETED

Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies

Lead Sponsor:

National Institute of Neurological Disorders and Stroke (NINDS)

Conditions:

Dermatomyositis

Inclusion Body Myositis

Eligibility:

All Genders

Phase:

PHASE2

Brief 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 (endomysiu...

Detailed Description

The inflammatory myopathies are a group of acquired muscle diseases characterized by subacute onset of progressive proximal muscle weakness, elevated serum muscle enzymes and endomysial inflammation. ...

Eligibility 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.

Key Trial Info

Start Date :

May 1 1990

Trial Type :

INTERVENTIONAL

End Date :

July 1 2002

Estimated Enrollment :

120 Patients enrolled

Trial Details

Trial ID

NCT00001261

Start Date

May 1 1990

End Date

July 1 2002

Last Update

March 4 2008

Active Locations (1)

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Page 1 of 1 (1 locations)

1

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, United States, 20892

Intravenousimmunoglobulin (IVIg) for the Treatment of Inflammatory Myopathies | DecenTrialz