Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-04 @ 3:43 AM
Study NCT ID:
NCT03250169
Status:
TERMINATED
Last Update Posted:
2022-02-25
First Post:
2017-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurofilaments for NEDA Assessing in MS
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074323', 'term': 'Alemtuzumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Under recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2017-07-19', 'studyFirstSubmitQcDate': '2017-08-10', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood and CSF neurofilaments in Alemtuzumab patients over 24months', 'timeFrame': '2 years', 'description': 'Neurofilaments'}], 'secondaryOutcomes': [{'measure': 'Overall clinical response based on neurofilament response', 'timeFrame': '2 years', 'description': 'neurofilaments'}, {'measure': 'Neurofilament status and association with clinical and MRI markers of disease activity.', 'timeFrame': '2 years', 'description': 'Correlation index'}, {'measure': 'Longitudinal assessment of other biomarkers of inflammation & plasticity', 'timeFrame': '2 years', 'description': 'Correlation index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Goal is to evaluate the achievement of biological NEDA as demonstrated by a drop in neurofilament levels in MS patients commencing Alemtuzumab therapy as part of their MS management.', 'detailedDescription': 'Primary\n\n1. To evaluate the achievement of NEDA using blood and CSF neurofilaments in Alemtuzumab treated patients.\n\n Secondary\n2. To assess prognosis at the end of the study based on neurofilament status.\n3. To correlate neurofilament levels with clinical and MRI markers of disease activity.\n4. To evaluate the effect of Alemtuzumab on the profile of other CSF, blood, urine, faeces biomarkers of inflammation, neurodegeneration, neuronal sprouting and synaptogenesis, treatment activity and metabolic activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Relapsing-remitting MS', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).\n2. Age 18-55 years.\n3. EDSS score between 0-5.5.\n4. Commencing Alemtuzumab therapy at Neurology Infusion and Planned Investigation Unit, The Royal London Hospital, Ward 11D\n\nExclusion Criteria:\n\n1. A diagnosis of Secondary Progressive MS (SPMS) or other forms of progressive MS.\n2. Those unable to comply with study requirement'}, 'identificationModule': {'nctId': 'NCT03250169', 'briefTitle': 'Neurofilaments for NEDA Assessing in MS', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'Neurofilament Heavy and Light Chain Testing for NEDA (No Evidence of Disease Activity) Assessing in Multiple Sclerosis: a Longitudinal Biomarker Study', 'orgStudyIdInfo': {'id': '011717'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Alemtuzumab', 'type': 'DRUG', 'description': 'Licensed dose'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1 2AT', 'city': 'London', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Queen Mary University of London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}