Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT06459232
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2024-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-10', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by DMT Use', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)'}], 'secondaryOutcomes': [{'measure': 'Mean Age', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Age Group', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy', 'description': 'Age group categories included:\n\n* 18-34 years\n* 35-44 years\n* 45-54 years\n* 55-64 years\n* 65+ years'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by Age Group', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy', 'description': 'Age group categories included:\n\n* 18-34 years\n* 35-44 years\n* 45-54 years\n* 55-64 years\n* 65+ years'}, {'measure': 'Number of Patients with a Minimum of 6 months Follow-up by Gender', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 12 months Follow-up by Gender', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type', 'timeFrame': 'Index date, defined as the date of the first claim for siponimod or MS-specific therapy'}, {'measure': 'Percentage of Patients with MS Relapses', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim'}, {'measure': 'Mean Charlson Comorbidity Index (CCI) Score', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim', 'description': 'CCI predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the CCI, categorized as low (0-1) and high (≥2).'}, {'measure': 'Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim', 'description': 'Disability levels included: No symptoms, Mild, Moderate, and Severe.'}, {'measure': 'Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim', 'description': 'Disability levels included: No symptoms, Mild, Moderate, and Severe.'}, {'measure': 'Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim'}, {'measure': 'Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim'}, {'measure': 'Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim'}, {'measure': 'Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT', 'timeFrame': 'Baseline, defined as the 12 months prior to the first observed MS therapy claim'}, {'measure': 'Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up', 'timeFrame': '6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)', 'description': 'Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.'}, {'measure': 'Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up', 'timeFrame': '12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)', 'description': 'Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.'}]}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.\n\nThe data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This was a retrospective, noninterventional cohort study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.\n* With 1 or more MS diagnosis for 12 months prior to the index date \\[inclusive\\].\n* Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date \\[inclusive\\].\n* Include patients who were 18 years or older on the index date.\n* Include patients continuously enrolled in pharmacy and medical benefits from the index date \\[inclusive\\] to 6 months/12 months post-index date.\n\nExclusion criteria\n\n• Patients with 1 or more claims of index drug within 12 months prior to index date.'}, 'identificationModule': {'nctId': 'NCT06459232', 'briefTitle': 'Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies', 'orgStudyIdInfo': {'id': 'CBAF312AUS16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Multiple Sclerosis (MS) Cohort', 'description': 'Adult MS patients with at least 1 claim of siponimod or an MS-related FDA-approved DMT.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Pharmaceuticals', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}