Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2025-12-28 @ 2:20 PM
Study NCT ID:
NCT00336557
Status:
COMPLETED
Last Update Posted:
2013-10-30
First Post:
2006-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1230}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-29', 'studyFirstSubmitDate': '2006-06-12', 'studyFirstSubmitQcDate': '2006-06-12', 'lastUpdatePostDateStruct': {'date': '2013-10-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects whose high dose IFN therapy had changed in the regularly scheduled NAbs testing arm versus the Usual Care Arm', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'The nature of any therapy/management change in each arm', 'timeFrame': '1 year'}, {'measure': 'Reason for change in therapy/management', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['High-Dose Interferon', 'Neutralizing Antibodies'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.', 'detailedDescription': 'An observational study to determine the impact of multiple neutralizing antibody (NAb) tests on treatment patterns compared to the usual care of MS patients receiving high-dose IFN therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects who have been on high-dose Interferon (IFN) for 1 to 4 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Willing to provide informed consent.\n* Male or female, 18 years of age or older, with a diagnosis of MS.\n\nExclusion Criteria:\n\n* Has been on oral or parenteral corticosteroid therapy within the two weeks prior to the Baseline Visit.\n* Has been treated with immunoglobulins (IgG) or plasmapheresis within the last six months.\n* Has any condition which the investigator or nurse feels may interfere with participation in the study or with assessments for the full duration of the study.\n* Previously participated in this study.\n* Has received an experimental drug in the last thirty (30) days.'}, 'identificationModule': {'nctId': 'NCT00336557', 'briefTitle': 'Determine Impact of Multiple NAb Tests on Treatment Compared to Usual Care of MS Patients on High-dose IFN Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Randomized, Controlled, Open-Label Parallel Group Study to Evaluate the Effect of Regularly Scheduled Neutralizing Antibody Testing on Treatment Patterns Versus Usual Care in High-Dose Interferon Treated Patients', 'orgStudyIdInfo': {'id': 'PM028'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regularly Scheduled NAb Testing Arm', 'description': 'Subjects will be scheduled for 5 study visits over the course of 12 months and any NAbs test results will be available to the investigator during the study.', 'interventionNames': ['Procedure: NAbs testing']}, {'label': 'Usual Care Arm', 'description': "Subjects will be scheduled for 2 study visits over the course of 12 months and any NAbs test results will be unknown by the investigator until the conclusion of the subject's study participation."}], 'interventions': [{'name': 'NAbs testing', 'type': 'PROCEDURE', 'description': 'blood drawn for a Binding Antibody (BAb) and Neutralizing Antibody (NAb) test.', 'armGroupLabels': ['Regularly Scheduled NAb Testing Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Neurological Associates, LTD', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94705', 'city': 'Berkley', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Physicians Medical Group'}, {'zip': '93710', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Neuro-Pain Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Fullerton Neurology and Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94960', 'city': 'San Anselmo', 'state': 'California', 'country': 'United States', 'facility': 'Neurology Clinic of Marin', 'geoPoint': {'lat': 37.97465, 'lon': -122.56164}}, {'zip': '80910', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates, PC', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80113', 'city': 'Engelwood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Neurosurgery'}, {'zip': '33308', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'The Emery Neuroscience Center', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, PA', 'geoPoint': {'lat': 28.62778, 'lon': -81.36312}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'country': 'United States', 'facility': 'Collier Neurologic Specialitsts', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '33609', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Axiom Clinical Research of Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'University of South Florida', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Medical College of Georgia Augusta MS Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '61801', 'city': 'Urbana', 'state': 'Illinois', 'country': 'United States', 'facility': 'Carle Clinic Association', 'geoPoint': {'lat': 40.11059, 'lon': -88.20727}}, {'zip': '01747', 'city': 'Hopedale', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Neurology Associates', 'geoPoint': {'lat': 42.13065, 'lon': -71.54117}}, {'zip': '02124', 'city': 'Lexinton', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Lahey Clinic'}, {'zip': '02190', 'city': 'South Weymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'South Shores Neurology Associates, INC', 'geoPoint': {'lat': 42.1751, 'lon': -70.94949}}, {'zip': '48080', 'city': 'Saint Clair Shores', 'state': 'Michigan', 'country': 'United States', 'facility': 'Michigan Neurology Associates', 'geoPoint': {'lat': 42.49698, 'lon': -82.88881}}, {'zip': '56001', 'city': 'Mankato', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mankato Clinic', 'geoPoint': {'lat': 44.15906, 'lon': -94.00915}}, {'zip': '65201', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Columbia Center for Neurology and MS', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': "St John's Mercy Medical Center", 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59405', 'city': 'Great Falls', 'state': 'Montana', 'country': 'United States', 'facility': 'Advanced Neurology Specialist', 'geoPoint': {'lat': 47.50024, 'lon': -111.30081}}, {'zip': '68123', 'city': 'Bellvue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Creighton University Department of Neurology'}, {'zip': '07960', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'The Neuroscience Center of Northern NJ', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Neurology Associates of Albany, P.C.', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Hospital for Join Diseases, MS Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11772', 'city': 'Patchogue', 'state': 'New York', 'country': 'United States', 'facility': 'Comprehensive MS Care Clinic at South Shore Neurology', 'geoPoint': {'lat': 40.76565, 'lon': -73.01511}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Multiple Sclerosis Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28806', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Asheville Neurology Specialist, PA', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '27834', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'East Carolina Neurology', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '29615', 'city': 'Greenville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Alliance for Neuro Research, LLC Absher Neurology', 'geoPoint': {'lat': 35.61266, 'lon': -77.36635}}, {'zip': '27607', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Raleigh Neurology Associates', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '28144', 'city': 'Salisbury', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Central Carolina Neurology & Sleep', 'geoPoint': {'lat': 35.67097, 'lon': -80.47423}}, {'zip': '44718', 'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'NeuroCare Center', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'zip': '45408', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Neurology Specialists, Inc', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '44685', 'city': 'Uniontown', 'state': 'Ohio', 'country': 'United States', 'facility': 'Oak Clinic', 'geoPoint': {'lat': 40.97506, 'lon': -81.40817}}, {'zip': '97504', 'city': 'Medford', 'state': 'Oregon', 'country': 'United States', 'facility': 'Medford Neurological Clinic,Inc', 'geoPoint': {'lat': 42.32652, 'lon': -122.87559}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Neurological Associates', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '18301', 'city': 'East Stroudsburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Neurology Associates of Monroe County', 'geoPoint': {'lat': 40.99954, 'lon': -75.18129}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'North Shore Clinical Associates', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '02886', 'city': 'Warwick', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'NeuroHealth, INC', 'geoPoint': {'lat': 41.7001, 'lon': -71.41617}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Mid-South Physicians', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78681', 'city': 'Round Rock', 'state': 'Texas', 'country': 'United States', 'facility': 'Central Texas Neurology', 'geoPoint': {'lat': 30.50826, 'lon': -97.6789}}, {'zip': '78212', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Center of San Antonio, P.A.', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78232', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Neurology Center of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain Multiple Sclerosis Clinic', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Dean Health System', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Stephen Glenski, PharmD', 'role': 'STUDY_CHAIR', 'affiliation': 'Teva Neuroscience, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}