Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-28 @ 5:56 PM
Study NCT ID:
NCT01539395
Status:
WITHDRAWN
Last Update Posted:
2020-09-02
First Post:
2012-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis
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_WITH_DNA', 'description': 'Blood remaining after testing for MSDx Complex-1 will be retained for evaluation for other MS biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-24', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarker Differential', 'timeFrame': 'Baseline', 'description': 'A difference in the levels of Complex-1 between subjects with controlled, stable MS vs. subjects in acute MS relapse'}], 'secondaryOutcomes': [{'measure': 'Biomarker reduction with steroid therapy', 'timeFrame': '3 months', 'description': 'A decrease in the level of MSDx Complex-1 in response to steroid therapy for a relapse of MS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing Remitting', 'MS'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who currently diagnosed with relapsing remitting multiple sclerosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 45 years or older of either gender and of any racial/ethnic group.\n2. Subjects must be in generally good health.\n3. Subjects must be able and willing to comply with the requirements of the protocol.\n4. Must be diagnosed with RRMS\n5. Meets the criteria to enter Group 1 or Group 2\n\nExclusion Criteria:\n\n1. Subject is currently in middle of an active episode of an autoimmune condition (e.g. rheumatoid arthritis, system lupus erythematosis)\n2. Subject currently has a condition such as active influenza that would stimulate the immune system'}, 'identificationModule': {'nctId': 'NCT01539395', 'briefTitle': 'A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MSDx, Inc.'}, 'officialTitle': 'A Cross-Sectional Study of MSDx Complex 1 as a Marker for Active Disease in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'MSDX0211'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Inactive Disease', 'description': 'Inactive disease; RRMS patients who have been treated with monthly infusions of Tysabri for 12 months and have had stable disease for the last 6 months or more and show stable or improving neurological deficits over 3 months on Tysabri.', 'interventionNames': ['Other: MSDx Complex-1 Biomarker Test']}, {'label': 'Active Disease', 'description': 'Active disease; RRMS patients in acute clinical relapse or with active MRI. Blood sample obtained within 30 days of event AND before steroid treatment (or) patients in early disease on or off first line agents with relapse in prior 3 months AND not treated with steroids for at least 2 months.', 'interventionNames': ['Other: MSDx Complex-1 Biomarker Test']}, {'label': 'Active Disease - Steroid Therapy', 'description': 'Patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin steroid therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).', 'interventionNames': ['Other: MSDx Complex-1 Biomarker Test']}], 'interventions': [{'name': 'MSDx Complex-1 Biomarker Test', 'type': 'OTHER', 'description': 'A biomarker test for the level of MSDx Complex-1', 'armGroupLabels': ['Active Disease', 'Active Disease - Steroid Therapy', 'Inactive Disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Jeanette K Wendt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest NeuroSpecialists, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MSDx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}