Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2025-12-26 @ 3:35 AM
Study NCT ID:
NCT01541618
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2012-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'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 the biomarker test is completed will be retained for possible evaluation of additional biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2012-02-21', 'studyFirstSubmitQcDate': '2012-02-29', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in MSDX Complex-1 between baseline and 6-month visit', 'timeFrame': '6 months', 'description': 'This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS.'}], 'secondaryOutcomes': [{'measure': 'Gadolinium MRI and MSDX Complex-1 level', 'timeFrame': '6 months', 'description': 'This outcome will evaluate whether a change seen in a Gadolinium MRI (a diagnostic test for MS) matches with a change in the MSDX Complex-1 level in a patient with MS.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['MS', 'RRMS', 'RR Multiple Sclerosis'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '45 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study populations for this study is a patient with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of clinically definite relapsing remitting MS (RRMS)\n2. Age 45 years and older\n3. Willing and able to provide written informed consent\n4. Patient has high disease activity.\n5. Patient is about to begin Natalizumab (Tysabri) therapy.\n\nExclusion Criteria:\n\n1. Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS\n2. Known infectious or hematological disease.\n3. Unwilling or unable to comply with the requirements of this protocol\n4. Subject can not have a gadolinium enhanced MRI'}, 'identificationModule': {'nctId': 'NCT01541618', 'briefTitle': 'A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'MSDx, Inc.'}, 'officialTitle': 'A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'MSDX-0411'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tysabri Group', 'description': 'Patients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) 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', 'otherNames': ['Biomarker Test'], 'description': 'MSDX Complex-1 Biomarker test', 'armGroupLabels': ['Tysabri Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Northwest NeuroSpecialists, PLLC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Jeannette Wendt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northwest NeuroSpecialists, PLLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MSDx, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}