Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT03933202
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2019-04-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-11-20', 'releaseDate': '2025-11-11'}, {'releaseDate': '2025-12-12'}], 'estimatedResultsFirstSubmitDate': '2025-11-11'}}, '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': 'D017338', 'term': 'Cladribine'}], 'ancestors': [{'id': 'D015762', 'term': '2-Chloroadenosine'}, {'id': 'D000241', 'term': 'Adenosine'}, {'id': 'D011684', 'term': 'Purine Nucleosides'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003839', 'term': 'Deoxyadenosines'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2019-04-29', 'studyFirstSubmitQcDate': '2019-04-29', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Annualized Relapse Rate (ARR) (Prospective Assessment)', 'timeFrame': 'Baseline (Month 0) up to 24 Months', 'description': 'A relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in 14-Item Treatment Satisfaction Questionnaire for Medication (TSQM-14) Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Change From Baseline in 36-Item Short Form Health Survey (SF-36) Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Change From Baseline in Modified Fatigue Impact Scale - 5-item version (MFIS-5) Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Change From Baseline in 7-Item Beck-Depression Inventory-Fast Screen (BDI-FS) Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Change From Baseline in 6-Item Work Productivity Activity Impairment - Multiple Sclerosis (WPAI-MS) Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Change From Baseline in Patient Determined Disease Steps (PDDS) Scale Total Score at Month 6, 12 and 24', 'timeFrame': 'Baseline (Month 0), Month 6, 12 and 24'}, {'measure': 'Number of Participants With Adherence to Treatment as Assessed by Modified Versions of the Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ)', 'timeFrame': 'Baseline (Month 0) and at the end of Months 1, 2, 13 and 14'}, {'measure': 'Percentage of Participants with Relapse (Prospective Assessment)', 'timeFrame': 'Month 12 and 24', 'description': 'A relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.'}, {'measure': 'Percentage of Participants With Relapse Associated With Hospitalization, Diagnosis or Reason for Hospitalization', 'timeFrame': 'Month 12 and 24', 'description': 'A relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse associated with hospitalization, diagnosis or reason for hospitalization will be reported.'}, {'measure': 'Percentage of Participants With Relapse Associated With Glucocorticoid Use', 'timeFrame': 'Month 12 and 24', 'description': 'A relapse will be defined as per routine clinical practice as determined by the investigator. As a guide, relapse may be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. Percentage of participants with relapse associated with glucocorticoid use up to 24 months of treatment with cladribine tablets, after baseline (prospectively collected data) will be reported.'}, {'measure': 'Treatment Pattern as Evaluated by Number of Participants With Previous Treatment for Multiple Sclerosis (MS)', 'timeFrame': 'At Baseline (Month 0)'}, {'measure': 'Percentage of Participants Who Discontinue Cladribine Tablets', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Percentage of Participants With Reason for Discontinuation of Cladribine Tablets', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Elapsed Time to Discontinuation After First Dose of Cladribine Tablets', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Number of Doses Received by Participants as per United States Prescribing Information', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Percentage of Planned Doses Received by Participants as per United States Prescribing Information', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Number of Participants with Subsequent Treatment Chosen Following Discontinuation of Cladribine Tablets', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Number of Participants Assessed of Concomitant Multiple Sclerosis Medications Used During Study Period', 'timeFrame': 'Baseline (Month 0) up to 24 Months'}, {'measure': 'Annualized Relapse Rate (ARR) (Retrospective Assessment)', 'timeFrame': 'Up to 24 Months prior Baseline (Month 0)', 'description': 'A relapse will be defined as exacerbation of symptoms that occur over a minimum of 24 hours and separated from a previous attack by at least 30 days, in the absence of fever or infection. ARR up to 24 months prior to baseline (retrospectively collected data) will be reported.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Adverse Events of Special Interest (AESIs) and Special Situations', 'timeFrame': 'Baseline (Month 0) up to 24 months', 'description': "A serious adverse event (SAE) is an adverse event (AE) that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or is otherwise considered medically important. An ADR is a response to a medicinal product which is noxious and unintended. An AESI is an AE of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the investigator to the Sponsor can be appropriate."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis', 'Cladribine Tablets', 'Observational', 'Mavenclad'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '33517769', 'type': 'DERIVED', 'citation': 'Miravalle AA, Katz J, Robertson D, Hayward B, Harlow DE, Lebson LA, Sloane JA, Bass AD, Fox EJ. CLICK-MS and MASTER-2 Phase IV trial design: cladribine tablets in suboptimally controlled relapsing multiple sclerosis. Neurodegener Dis Manag. 2021 Apr;11(2):99-111. doi: 10.2217/nmt-2020-0059. Epub 2021 Feb 1.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0079', 'label': 'Trial Awareness and Transparency website'}, {'url': 'https://medical.emdserono.com/en_US/home.html', 'label': 'US Medical Information website, Medical Resources'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the effectiveness, safety and Patient-Reported Outcomes (PROs) of cladribine tablets in participants with RMS including relapsing-remitting multiple sclerosis (RRMS) and active secondary progressive multiple sclerosis (aSPMS), who transition to cladribine tablets after suboptimal response to any oral or infusion Disease-Modifying Drugs (DMDs) approved in the United States (US) for RMS in a real-world-setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with relapsing form of Multiple Sclerosis (RMS) including active secondary progressive multiple sclerosis (aSPMS).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed informed consent\n* Have diagnosis of RMS, including RRMS and aSPMS, and satisfy the approved indication for cladribine tablets as per United States Prescribing Information (USPI)\n* Have time since diagnosis of RMS of at least 12 months\n* In the opinion of the investigator, experienced suboptimal response (lack of effectiveness, intolerability, poor adherence) to oral or infusion DMD treatment other than cladribine tablets\n* Had received their last previous oral DMD for at least 1 month or at least 1 dose of their last previous infusion DMD\n* Have decided to initiate treatment with cladribine tablets during routine clinical care\n* Meet criteria as per the approved USPI\n* Have access to a valid e-mail address\n\nExclusion Criteria:\n\n* Have been previously treated with cladribine in any dosing form (intravenous, subcutaneous, or oral)\n* Transitioning from previous oral DMD solely for administrative reasons such as relocation\n* Have comorbid conditions that preclude participation\n* Have any clinical condition or medical history noted as contraindication on USPI\n* Are currently participating in an interventional clinical trial\n* Pregnant or breastfeeding women, women who plan to become pregnant or men whose partner plans to become pregnant during study the cladribine treatment period'}, 'identificationModule': {'nctId': 'NCT03933202', 'briefTitle': 'A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMD Serono'}, 'officialTitle': 'Cladribine Tablets: Observational Evaluation of Effectiveness and PROs in Suboptimally Controlled Patients Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)', 'orgStudyIdInfo': {'id': 'MS700568_0079'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cladribine Tablets', 'description': "No intervention will be administered as a part of this study. Participants who had decided prior to enrollment to transition from any oral or infusion DMD to treatment with cladribine tablets under routine clinical care and who meet all eligibility criteria will receive an initial treatment course with cladribine tablets in Year 1 and are planned to receive a second course in Year 2, as per the approved United States Prescribing Information (USPI). Data sources for this study will include data extracts from participants' medical records performed by site personnel as well as questionnaires directly filled out by participants.", 'interventionNames': ['Drug: Cladribine Tablets']}], 'interventions': [{'name': 'Cladribine Tablets', 'type': 'DRUG', 'description': 'No intervention will be administered as a part of this study. Participants will receive cladribine tablets as per investigator discretion and as per United States approved label: 3.5 milligram/kilogram (mg/kg) body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.', 'armGroupLabels': ['Cladribine Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates, P.C.', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '36693', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of South Alabama', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas for Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'Fullerton Neurology and Headache Center', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90048', 'city': 'West Hollywood', 'state': 'California', 'country': 'United States', 'facility': 'Regina Berkovich MD PhD INC', 'geoPoint': {'lat': 34.09001, 'lon': -118.36174}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Springs Neurological Associates, PC - Neurology', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'HCA Research Institute', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '80528', 'city': 'Fort Collins', 'state': 'Colorado', 'country': 'United States', 'facility': 'Advanced Neurosciences Research, LLC', 'geoPoint': {'lat': 40.58526, 'lon': -105.08442}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Associated Neurologists of Southern Connecticut, PC', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '06824', 'city': 'Fairfield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.14121, 'lon': -73.26373}}, {'zip': '32751', 'city': 'Maitland', 'state': 'Florida', 'country': 'United States', 'facility': 'Neurology Associates, P. 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MultiCare Health System Institute for Research and', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Health System Institute for Research and Innovation - MultiCare Health System Institute for Research', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53215', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Ascension St. Francis Center for Neurological Disorders, S.C.', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'The Medical College of Wisconsin - Endocrinology', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'zip': '54956', 'city': 'Neenah', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Neuroscience Group of Northeast Wisconsin - DUPLICATE', 'geoPoint': {'lat': 44.18582, 'lon': -88.46261}}], 'overallOfficials': [{'name': 'Medical Responsible', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EMD Serono Inc., the biopharmaceutical division of Merck KGaA, Darmstadt, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMD Serono Research & Development Institute, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Merck KGaA, Darmstadt, Germany', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-11', 'type': 'RELEASE'}, {'date': '2025-11-20', 'type': 'RESET'}], 'unpostedResponsibleParty': 'EMD Serono Research & Development Institute, Inc.'}}}}