Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-26 @ 1:41 PM
Study NCT ID:
NCT01945359
Status:
COMPLETED
Last Update Posted:
2015-10-16
First Post:
2013-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design
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_WITHOUT_DNA', 'description': 'Serum Samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-14', 'studyFirstSubmitDate': '2013-09-13', 'studyFirstSubmitQcDate': '2013-09-13', 'lastUpdatePostDateStruct': {'date': '2015-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Stability', 'timeFrame': '8 Months', 'description': 'Disease stability as measured by stable Expanded Disability Status Scale (EDSS) and no significant changes on magnetic resonance imaging lesions or relapses.'}], 'secondaryOutcomes': [{'measure': 'Quantify disease stability', 'timeFrame': '8 months', 'description': 'Disease stability will also be assessed by examining annualized relapse rate, proportion of patients experience relapses, Visual Analog Scale (VAS), Modified Fatigue Impact Scale (MFIS), Symbol Digit Modalities Test (SDMT) and pharmacodynamic and pharmacokinetic blood markers.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing Multiple Sclerosis', 'Dimethyl Fumarate', 'Natalizumab'], 'conditions': ['Relapsing Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This study will observe participants with relapsing remitting multiple sclerosis who are switching therapies from natalizumab to dimethyl fumarate to determine disease stability.', 'detailedDescription': "This is an investigator initiated, single site, open-label, single arm observational study examining the initial efficacy and tolerability of dimethyl fumarate in a real world clinical setting for patients with a relapsing form of Multiple Sclerosis (MS) when crossed over from natalizumab therapy.\n\nThe decision to cross over from natalizumab to DMF will be made by the patient and the prescribing physician and must precede enrollment in the study.\n\nMS disease status and history will be gathered from the patient's medical records. Patients will be followed for the first 24 weeks of their transition from natalizumab. Assessments will be performed at Baseline and every 4 weeks thereafter for 24 weeks. These assessments may include:\n\n* Expanded Disability Status Scale (EDSS)\n* Relapse Assessment\n* Patient Reported Outcomes (PRO) including quality of life, fatigue, and cognition outcome measures\n* Magnetic Resonance Imaging (MRI)\n* Laboratory testing\n\nStudy drop outs due to DMF intolerability or other etiologies will be encouraged to complete the trial even if placed on alternative therapies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '30 participants with relapsing remitting multiple sclerosis crossing over from natalizumab to dimethyl fumarate (DMF) therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. JCV Indec of 1.5 of greater and currently receiving natalizumab therapy for at least 24 months\n2. Decision to treat with DMF must precede enrollment\n3. Ability to understand the purpose and risk of the study and provide authorization for the use of protected health information in accordance with the monitoring agency\n4. Men or women \\>= 18 years at time of informed consent\n5. Naive to DMF or fumaric acid esters\n6. Confirmed diagnosis of a relapsing form of MS as verified by their treating physician\n\nExclusion Criteria:\n\n1. Inability ot comply with study requirements as outlined in the informed consent\n2. Known active malignancies or any other major co morbidity that, in the opinion of the Investigator, would affect the outcome of the study\n3. Pregnancy or breastfeeding\n4. Previous treatment with dimethyl fumarate'}, 'identificationModule': {'nctId': 'NCT01945359', 'acronym': 'IIT6', 'briefTitle': 'Pilot Study to Assess Disease Stability in a Natalizumab to Dimethyl Fumarate Crossover Design', 'organization': {'class': 'OTHER', 'fullName': 'Rocky Mountain MS Research Group, LLC'}, 'officialTitle': 'A Pilot Study to Assess Disease State Stability, Efficacy, and Tolerability in a Natalizumab to Dimethyl Fumarate Crossover Design', 'orgStudyIdInfo': {'id': '006-001-TEC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Relapsing Remitting MS (RRMS)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '84103', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Rocky Mountain MS Research Group', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'John F Foley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'President, Rocky Mountain MS Research Group'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rocky Mountain MS Research Group, LLC', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biogen', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'President, Rocky Mountain MS Research Group', 'investigatorFullName': 'John F. Foley, MD', 'investigatorAffiliation': 'Rocky Mountain MS Research Group, LLC'}}}}