Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-02 @ 10:58 PM
Study NCT ID:
NCT00683969
Status:
COMPLETED
Last Update Posted:
2008-05-26
First Post:
2008-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-05-23', 'studyFirstSubmitDate': '2008-05-19', 'studyFirstSubmitQcDate': '2008-05-23', 'lastUpdatePostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-05-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects reaching responder status', 'timeFrame': 'Week 36'}], 'secondaryOutcomes': [{'measure': 'Time to start of response', 'timeFrame': 'Event driven'}, {'measure': 'Mean and median prednisone dose and cholinesterase inhibitor dose', 'timeFrame': 'Week 36'}, {'measure': 'Adverse events, lab parameters, vital signs', 'timeFrame': 'Throughout study'}]}, 'conditionsModule': {'conditions': ['Myasthenia Gravis, Generalized']}, 'referencesModule': {'references': [{'pmid': '25032816', 'type': 'DERIVED', 'citation': 'Sengupta M, Cheema A, Kaminski HJ, Kusner LL; Muscle Study Group. Serum metabolomic response of myasthenia gravis patients to chronic prednisone treatment. PLoS One. 2014 Jul 17;9(7):e102635. doi: 10.1371/journal.pone.0102635. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The efficacy and safety of CellCept (1g po, bid for 36 weeks) will be assessed in patients with myasthenia gravis receiving prednisone, or other corticosteroids. During the study, patients will undergo gradual corticosteroid dose reduction, if they respond to treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients 18 to 80 years of age;\n* diagnosis of myasthenia gravis;\n* history of myasthenia weakness involving more than ocular (ie eye) or peri-ocular muscle;\n* duration of myasthenia gravis symptoms (including ocular symptoms) \\<=10 years;\n* prednisone dose \\>=20 mg/day (or equivalent alternate-day dose) for \\>=4 weeks.\n\nExclusion Criteria:\n\n* female patients who are pregnant, breastfeeding, or lactating;\n* regularly scheduled plasma exchange (PE) or intravenous immunoglobulin (IVIG) treatment, or PE or IVIG treatment within 2 weeks prior to randomization;\n* any prior clinically significant use of CellCept or other immunosuppressive therapy (except corticosteroids), or within 8 weeks prior to randomization.'}, 'identificationModule': {'nctId': 'NCT00683969', 'briefTitle': 'A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis', 'nctIdAliases': ['NCT00090636'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia Gravis', 'orgStudyIdInfo': {'id': 'WX17798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: mycophenolate mofetil (CellCept)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'mycophenolate mofetil (CellCept)', 'type': 'DRUG', 'description': '1g bid for 36 weeks', 'armGroupLabels': ['1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'po bid for 36 weeks', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66160-7314', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '14607', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599-7025', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19013-3395', 'city': 'Upland', 'state': 'Pennsylvania', 'country': 'United States', 'geoPoint': {'lat': 39.85261, 'lon': -75.38269}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': 'T6G 2B7', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'city': 'Bordeaux', 'country': 'France', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'city': 'Nice', 'country': 'France', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '40225', 'city': 'Düsseldorf', 'country': 'Germany', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}, {'zip': '81675', 'city': 'München', 'country': 'Germany', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '93053', 'city': 'Regensburg', 'country': 'Germany', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Hyderabad', 'country': 'India', 'geoPoint': {'lat': 17.38405, 'lon': 78.45636}}, {'city': 'Mumbai', 'country': 'India', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'New Delhi', 'country': 'India', 'geoPoint': {'lat': 28.62137, 'lon': 77.2148}}, {'zip': '12000', 'city': 'Jerusalem', 'country': 'Israel', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'zip': '20133', 'city': 'Milan', 'country': 'Italy', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '185', 'city': 'Roma', 'country': 'Italy', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20097', 'city': 'San Donato Milanese', 'country': 'Italy', 'geoPoint': {'lat': 45.41047, 'lon': 9.26838}}, {'zip': '06700', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '06726', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '14000', 'city': 'Mexico City', 'country': 'Mexico', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}, {'zip': '2300 RC', 'city': 'Leiden', 'country': 'Netherlands', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'zip': '3015 GD', 'city': 'Rotterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': "Kazan'", 'country': 'Russia', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Moscow', 'country': 'Russia', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}, {'city': 'Nizhniy Novgorad', 'country': 'Russia'}, {'zip': '11000', 'city': 'Belgrade', 'country': 'Serbia and Montenegro'}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '61068', 'city': 'Kharkiv', 'country': 'Ukraine', 'geoPoint': {'lat': 49.98177, 'lon': 36.25475}}, {'city': 'Kiev', 'country': 'Ukraine', 'geoPoint': {'lat': 50.45466, 'lon': 30.5238}}, {'zip': '69035', 'city': 'Zaporizhzhya', 'country': 'Ukraine', 'geoPoint': {'lat': 47.85167, 'lon': 35.11714}}, {'zip': 'L9 1AE', 'city': 'Liverpool', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'OX2 6HE', 'city': 'Oxford', 'country': 'United Kingdom', 'geoPoint': {'lat': 51.75222, 'lon': -1.25596}}, {'zip': 'M6 8HD', 'city': 'Salford', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.48771, 'lon': -2.29042}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche, 973-235-5000'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aspreva Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Clinical Trials, Study Director', 'oldOrganization': 'Hoffmann-La Roche'}}}}