Nctid:
NCT00001287
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D011115", "term"=>"Polyneuropathies"}, {"id"=>"D020277", "term"=>"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating"}, {"id"=>"D003711", "term"=>"Demyelinating Diseases"}, {"id"=>"D010265", "term"=>"Paraproteinemias"}], "ancestors"=>[{"id"=>"D010523", "term"=>"Peripheral Nervous System Diseases"}, {"id"=>"D009468", "term"=>"Neuromuscular Diseases"}, {"id"=>"D009422", "term"=>"Nervous System Diseases"}, {"id"=>"D011129", "term"=>"Polyradiculoneuropathy"}, {"id"=>"D020274", "term"=>"Autoimmune Diseases of the Nervous System"}, {"id"=>"D001327", "term"=>"Autoimmune Diseases"}, {"id"=>"D007154", "term"=>"Immune System Diseases"}, {"id"=>"D002908", "term"=>"Chronic Disease"}, {"id"=>"D020969", "term"=>"Disease Attributes"}, {"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D001796", "term"=>"Blood Protein Disorders"}, {"id"=>"D006402", "term"=>"Hematologic Diseases"}, {"id"=>"D007160", "term"=>"Immunoproliferative Disorders"}], "browseLeaves"=>[{"id"=>"M13999", "name"=>"Polyneuropathies", "asFound"=>"Polyneuropathy", "relevance"=>"HIGH"}, {"id"=>"M22097", "name"=>"Polyradiculoneuropathy, Chronic Inflammatory Demyelinating", "asFound"=>"Chronic Inflammatory Demyelinating Polyneuropathy", "relevance"=>"HIGH"}, {"id"=>"M13178", "name"=>"Paraproteinemias", "asFound"=>"Paraproteinemias", "relevance"=>"HIGH"}, {"id"=>"M11962", "name"=>"Monoclonal Gammopathy of Undetermined Significance", "relevance"=>"LOW"}, {"id"=>"M6909", "name"=>"Demyelinating Diseases", "asFound"=>"Demyelinating Diseases", "relevance"=>"HIGH"}, {"id"=>"M14013", "name"=>"Polyradiculoneuropathy", "relevance"=>"LOW"}, {"id"=>"M13432", "name"=>"Peripheral Nervous System Diseases", "relevance"=>"LOW"}, {"id"=>"M12411", "name"=>"Neuromuscular Diseases", "relevance"=>"LOW"}, {"id"=>"M4629", "name"=>"Autoimmune Diseases", "relevance"=>"LOW"}, {"id"=>"M22094", "name"=>"Autoimmune Diseases of the Nervous System", "relevance"=>"LOW"}, {"id"=>"M10200", "name"=>"Immune System Diseases", "relevance"=>"LOW"}, {"id"=>"M6147", "name"=>"Chronic Disease", "relevance"=>"LOW"}, {"id"=>"M22700", "name"=>"Disease Attributes", "relevance"=>"LOW"}, {"id"=>"M5077", "name"=>"Blood Protein Disorders", "relevance"=>"LOW"}, {"id"=>"M9490", "name"=>"Hematologic Diseases", "relevance"=>"LOW"}, {"id"=>"M10206", "name"=>"Immunoproliferative Disorders", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}, {"id"=>"T1306", "name"=>"Chronic Inflammatory Demyelinating Polyneuropathy", "asFound"=>"Chronic Inflammatory Demyelinating Polyneuropathy", "relevance"=>"HIGH"}, {"id"=>"T3867", "name"=>"Monoclonal Gammopathy of Undetermined Significance", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Immune System Diseases", "abbrev"=>"BC20"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Blood and Lymph Conditions", "abbrev"=>"BC15"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D007136", "term"=>"Immunoglobulins"}, {"id"=>"D016756", "term"=>"Immunoglobulins, Intravenous"}, {"id"=>"D000906", "term"=>"Antibodies"}, {"id"=>"D005719", "term"=>"gamma-Globulins"}, {"id"=>"D018029", "term"=>"Rho(D) Immune Globulin"}], "ancestors"=>[{"id"=>"D007155", "term"=>"Immunologic Factors"}, {"id"=>"D045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M4225", "name"=>"Antibodies", "asFound"=>"Balloon", "relevance"=>"HIGH"}, {"id"=>"M10184", "name"=>"Immunoglobulins", "asFound"=>"Balloon", "relevance"=>"HIGH"}, {"id"=>"M19117", "name"=>"Immunoglobulins, Intravenous", "asFound"=>"Aqueous", "relevance"=>"HIGH"}, {"id"=>"M8836", "name"=>"gamma-Globulins", "asFound"=>"Aqueous", "relevance"=>"HIGH"}, {"id"=>"M20191", "name"=>"Rho(D) Immune Globulin", "asFound"=>"Aqueous", "relevance"=>"HIGH"}, {"id"=>"M10201", "name"=>"Immunologic Factors", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE2"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"primaryPurpose"=>"TREATMENT"}, "enrollmentInfo"=>{"count"=>60}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"1990-12"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2000-02", "completionDateStruct"=>{"date"=>"2001-01"}, "lastUpdateSubmitDate"=>"2008-03-03", "studyFirstSubmitDate"=>"1999-11-03", "studyFirstSubmitQcDate"=>"2002-12-09", "lastUpdatePostDateStruct"=>{"date"=>"2008-03-04", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"2002-12-10", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Intravenous High-Dose Immunoglobulin", "Monoclonal Gammopathies", "Peripheral Nerve Demyelination", "CIDP", "Chronic Inflammatory Demyelinating Polyneuropathy"], "conditions"=>["Demyelinating Diseases", "Paraproteinemias"]}, "referencesModule"=>{"references"=>[{"pmid"=>"7224612", "type"=>"BACKGROUND", "citation"=>"Dalakas MC, Engel WK. Chronic relapsing (dysimmune) polyneuropathy: pathogenesis and treatment. Ann Neurol. 1981;9 Suppl:134-45. doi: 10.1002/ana.410090719."}, {"pmid"=>"2153942", "type"=>"BACKGROUND", "citation"=>"Cook D, Dalakas M, Galdi A, Biondi D, Porter H. High-dose intravenous immunoglobulin in the treatment of demyelinating neuropathy associated with monoclonal gammopathy. Neurology. 1990 Feb;40(2):212-4. doi: 10.1212/wnl.40.2.212."}, {"pmid"=>"7962520", "type"=>"BACKGROUND", "citation"=>"Basta M, Dalakas MC. High-dose intravenous immunoglobulin exerts its beneficial effect in patients with dermatomyositis by blocking endomysial deposition of activated complement fragments. J Clin Invest. 1994 Nov;94(5):1729-35. doi: 10.1172/JCI117520."}]}, "descriptionModule"=>{"briefSummary"=>"Chronic Inflammatory Demylinating Polyneuropathy (CIDP) is an autoimmune condition affecting the nervous system. Researchers believe the immune system begins attacking the cells covering nerves called myelin. The destruction of myelin causes muscle weakness, loss of sensation, abnormal levels of protein in the fluid surrounding the brain (CSF), and slowing of the nervous system. The disease progresses slowly and disables patients suffering from it.\n\nCIDP is treated with steroids, plasmapheresis, and immunosuppressive drugs. Many patients initially respond to these treatments, but develop resistance to the therapy or experience side effects causing the treatments to be stopped.\n\nResearchers believe that intravenous immunoglobulin (IVIg) may provide patients with CIDP a safer and more effective alternative to standard therapies for the disease. IVIg is a drug that has been used successfully to treat other immune-related diseases of the nervous system. However, because IVIg is so expensive, researchers believe it should first be proven effective on a small group of patients.\n\nThe study will take 60 patients with CIDP 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 (\\>25%) in muscle strength.", "detailedDescription"=>"Chronic inflammatory demyelinating polyneuropathy (CIDP) is a slowly progressive disabling neuropathy characterized by subacute onset of muscle weakness, distal sensory deficit, elevated spinal fluid protein, and slow nerve conduction velocity with or without conduction block. A monoclonal gammopathy is at times present in the serum of some patients. Because immune-mediated mechanisms against peripheral nerve myelin are thought to be primarily responsible for the clinical manifestations of CIDP, the treatment of choice is with corticosteroids, plasmapheresis or immunosuppressive drugs. Although many patients initially respond to these agents, a large number of them become resistant or develop unacceptable side effects that necessitate their discontinuation. The need for a more effective and safe immunotherapy in CIDP patients prompted the present study using high-dose intravenous immunoglobulin (IVIg). IVIg is an immunomodulating agent which has been recently shown to be effective and safe in the treatment of a number of patients with immune-related neuromuscular diseases.\n\nThis is a double blind, randomized, placebo controlled, trial involving 60 patients, half of which will receive IVIg and the other half placebo (D5/W). Because IVIg is prohibitively expensive, a controlled trial is needed to provide convincing evidence of efficacy, and ensure that the benefit is not due to spontaneous improvement or to observer bias. The dose of IVIg is 2 GM/Kg divided into two daily doses administered monthly for six months. The drug will be considered effective if patients experience an increase of more than 25% in their baseline muscle strength. Muscle strength will be assessed with a series of objective dynamometric measurements performed before and after each monthly infusion."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "healthyVolunteers"=>false, "eligibilityCriteria"=>"Selected patients should have CIDP with or without an associated monoclonal gammopathy.\n\nSubjects should have clinical evidence of peripheral neuropathy with muscle weakness and sensory deficit.\n\nSubjects should have evidence of clinical, histological or family history of another neuromuscular illness.\n\nSubjects should have elevation of CSF protein during the course of the disease.\n\nSubjects should have demyelination by nerve conduction study and/or nerve biopsy.\n\nSuitable candidates for IVIg should be patients with active, bonefide CIDP who:\n\n1. 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\n2. 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.\n\nSubjects should not be pregnant or nursing.\n\nSubjects 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).\n\nNo subjects below 18 years of age.\n\nPatients should not have severe renal or hepatic disease and severe COPD or coronary artery disease.\n\nPatients should not be allergic to IVIg or have a known IgA deficiency."}, "identificationModule"=>{"nctId"=>"NCT00001287", "briefTitle"=>"Intravenous Immunoglobulin (IVIg) for the Treatment of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)", "organization"=>{"class"=>"NIH", "fullName"=>"National Institutes of Health Clinical Center (CC)"}, "officialTitle"=>"The Efficacy of High-Dose Intravenous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)", "orgStudyIdInfo"=>{"id"=>"910039"}, "secondaryIdInfos"=>[{"id"=>"91-N-0039"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"intravenous immunoglobulin (IVIg)", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"20892", "city"=>"Bethesda", "state"=>"Maryland", "country"=>"United States", "facility"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "geoPoint"=>{"lat"=>38.98067, "lon"=>-77.10026}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute of Neurological Disorders and Stroke (NINDS)", "class"=>"NIH"}}}}
