The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Date de début de l'étude : 1 décembre 1990

Selected patients should have CIDP with or without an associated monoclonal gammopathy. Subjects should have clinical evidence of peripheral neuropathy with muscle weakness and sensory deficit. Subjects should have evidence of clinical, histological or family history of another neuromuscular illness. Subjects should have elevation of CSF protein during the course of the disease. Subjects should have demyelination by nerve conduction study and/or nerve biopsy. Suitable candidates for IVIg should be patients with active, bonefide CIDP 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. or 2. have been additionally treated with one of the other immunosuppressive agents considered effective in some CIDP patients, such as azathioprine, chlorambucil, cyclophosphamide, cyclosporine or plasmapheresis but without benefit or with unacceptable side effects that had necessitated their discontinuation. Subjects should not be pregnant or nursing. Subjects should not be critically ill such as those requiring intravenous pressors for maintenance of cardiac output, patients with unstable respiratory insufficiency and patients with such severe muscle weakness requiring help for basic self care (Karnofsky performance scale less than 50). No subjects below 18 years of age. Patients should not have severe renal or hepatic disease and severe COPD or coronary artery disease. Patients should not be allergic to IVIg or have a known IgA deficiency.