Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:29 PM
Study NCT ID:
NCT01179893
Status:
COMPLETED
Last Update Posted:
2010-08-11
First Post:
2010-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2018-12-13', 'releaseDate': '2018-05-15'}], 'estimatedResultsFirstSubmitDate': '2018-05-15'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009157', 'term': 'Myasthenia Gravis'}], 'ancestors': [{'id': 'D020361', 'term': 'Paraneoplastic Syndromes, Nervous System'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010257', 'term': 'Paraneoplastic Syndromes'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020511', 'term': 'Neuromuscular Junction Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016756', 'term': 'Immunoglobulins, Intravenous'}], 'ancestors': [{'id': 'D007074', 'term': 'Immunoglobulin G'}, {'id': 'D007132', 'term': 'Immunoglobulin Isotypes'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-09', 'studyFirstSubmitDate': '2010-08-09', 'studyFirstSubmitQcDate': '2010-08-09', 'lastUpdatePostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quantitative Myasthenia Gravis Score (QMGS) from baseline to day 14 after treatment', 'timeFrame': 'QMGS at day 14, and patients followed to day 60', 'description': 'QMGS is a validated clinical measure of myasthenia gravis ranging from 0 points (no myasthenic weakness) to a maximum of 39 points, with a defined change of 3.4 units required for clinical significance.'}], 'secondaryOutcomes': [{'measure': 'QMGS Score change at days 21 and 28 from start of treatment.', 'timeFrame': '28 days', 'description': 'Change in QMGS with time to see if effect ad day 14 is sustained.'}, {'measure': 'Post intervention status', 'timeFrame': 'Day 14, 21 and 28', 'description': 'Categorical scale of improvement, worsening, or no change for myasthenia gravis.'}, {'measure': 'Single fiber electromyography: jitter, percent abnormal pair, percent blocking', 'timeFrame': 'Days 14 and 28 compared to baseline', 'description': 'Electrophysiological assessment of neuromuscular transmission.'}, {'measure': 'Repetitive Nerve stimulation studies', 'timeFrame': 'Days 14 and 28', 'description': 'Assessment of decrement'}, {'measure': 'Acetylcholine Receptor Antibody titers', 'timeFrame': 'Day 28 (if positive at baseline)', 'description': 'Laboratory assay of pathogenic antibody'}, {'measure': 'AntiMUSK antibody', 'timeFrame': 'Day 28 (if positive at baseline)', 'description': 'Laboratory measure of pathogenic antibody'}, {'measure': 'Need for ICU admission, ventilation, intubation', 'timeFrame': '60 days', 'description': 'Myasthenic deterioration and crisis'}, {'measure': 'Hospitalization', 'timeFrame': '60 days', 'description': 'Myasthenic deterioration and crisis'}, {'measure': 'Need for additional myasthenic treatment', 'timeFrame': 'Day 60', 'description': 'Myasthenic deterioration or crisis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Myasthenia Gravis', 'IVIG', 'PLEX'], 'conditions': ['Myasthenia Gravid']}, 'referencesModule': {'references': [{'pmid': '17353471', 'type': 'BACKGROUND', 'citation': 'Zinman L, Ng E, Bril V. IV immunoglobulin in patients with myasthenia gravis: a randomized controlled trial. Neurology. 2007 Mar 13;68(11):837-41. doi: 10.1212/01.wnl.0000256698.69121.45.'}]}, 'descriptionModule': {'briefSummary': 'Immunomodulation is effective in treating patients with myasthenia gravis (MG), but prior studies have not adequately defined if plasma exchange (PLEX) in superior to intravenous immunoglobulin (IVIG) in the treatment of myasthenia gravis. This study aimed to determine if PLEX was superior to IVIG in the treatment of patients with myasthenia gravis.\n\nPatients with MG requiring immunomodulation are randomized to IVIG or PLEX and treated with a full course of immunomodulation. The quantitative myasthenia gravis score (QMGS) will be evaluated as the primary efficacy parameter at day 14 to determine if PLEX is superior to IVIG.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* diagnosis of moderate-severe MG (defined as a Quantitative Myasthenia Gravis Score QMGS \\>10.5)\n* worsening weakness requiring a change in therapy judged by a neuromuscular expert\n\nExclusion Criteria:\n\n* Worsening weakness secondary to concurrent medications (e.g. Aminoglycosides)\n* Worsening weakness secondary to infection\n* Change in corticosteroid dosage in the 2 weeks prior to screening\n* Other disorders causing weakness or fatigue\n* Known absolute IgA deficiency (risk of anaphylactic reaction to IVIG)\n* History of anaphylaxis or severe systemic response to IVIG or albumin\n* Pregnancy or breastfeeding\n* Active renal failure precluding volume of IVIG (risk of volume overload with IVIG) as judged by the investigators\n* Clinically significant cardiac disease precluding IVIG volume as judged by the investigators\n* Known hyperviscosity or hypercoaguable state (risk of stroke with IVIG)\n* Known coagulopathy with bleeding\n* On another current study medication or protocol within 4 weeks of screening\n* Patients with known refractory status to either IVIG or PLEX\n* Poorly controlled or severe hypertension (exacerbation by IVIG)\n* Patient refuses treatment with either IVIG or PLEX\n* Patient refuses follow-up with electrophysiological studies\n* Patient unable or unwilling to give informed consent'}, 'identificationModule': {'nctId': 'NCT01179893', 'briefTitle': 'Intravenous Immunoglobulin and Plasma Exchange in Myasthenia Gravis', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Randomized Trial of Plasma Exchange vs. IVIG in the Treatment of Myasthenia Gravis', 'orgStudyIdInfo': {'id': '07-0280-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'IVIG', 'description': 'Intravenous Immunoglobulin, 2G/Kg, infused over 2 days in the Medical Day Unit of the University Health Network', 'interventionNames': ['Biological: IVIG']}, {'type': 'EXPERIMENTAL', 'label': 'PLEX', 'description': 'Patients received one plasma volume plasma exchanges with 5% albumin replacement fluid. Five plasma exchange procedures occurred every second day with breaks over the weekend allowed. Patients treated in the apheresis units at the University Health Network.', 'interventionNames': ['Procedure: PLEX']}], 'interventions': [{'name': 'IVIG', 'type': 'BIOLOGICAL', 'description': 'Intravenous immunoglobulin', 'armGroupLabels': ['IVIG']}, {'name': 'PLEX', 'type': 'PROCEDURE', 'description': 'Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.', 'armGroupLabels': ['PLEX']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University Health Network', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Vera Bril, BSc, MD, FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'David Barth, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Heatlh Network'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'Grifols Therapeutics LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Vera Bril', 'oldOrganization': 'University Health Network'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2018-05-15', 'type': 'RELEASE'}, {'date': '2018-12-13', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University Health Network, Toronto'}}}}