Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-07 @ 9:51 AM
Study NCT ID:
NCT05528666
Status:
COMPLETED
Last Update Posted:
2022-11-08
First Post:
2022-09-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk Perception in Multiple Sclerosis
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': 4361}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-07', 'studyFirstSubmitDate': '2022-09-02', 'studyFirstSubmitQcDate': '2022-09-02', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients who were switched based on risk perception (infections, malignancies, others)', 'timeFrame': 'Throughout the study, approximately 5 years (2017 to 2021)', 'description': 'Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.'}], 'secondaryOutcomes': [{'measure': 'Number of patients with ranking of the frequency of switches due to risk perception', 'timeFrame': 'Throughout the study, approximately 5 years (2017 to 2021)', 'description': 'Proportion of patients who were switched based on risk perception (infections, malignancies, others) were reported.'}, {'measure': 'Proportion of patients who switched due to lack of efficacy', 'timeFrame': 'Throughout the study, approximately 5 years (2017 to 2021)', 'description': 'Proportion of patients who switched due to lack of efficacy due to new or enlarging lesions on MRI, increase in the frequency and/or severity of the relapses, progression in physical disability measured by EDSS or patient compliance issues between groups were reported.'}, {'measure': 'Proportion of patients who changed treatment group versus patients who continued in the same treatment group', 'timeFrame': 'Throughout the study, approximately 5 years (2017 to 2021)', 'description': 'Proportion of patients who changed treatment group versus patients who continued in the same treatment group were reported.'}, {'measure': 'Number of relapses', 'timeFrame': 'Baseline', 'description': 'Number of relapses were reported.'}, {'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Baseline', 'description': 'The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.'}, {'measure': 'Age', 'timeFrame': 'Baseline', 'description': 'Age information reported'}, {'measure': 'Gender', 'timeFrame': 'Baseline', 'description': 'Gender information reported'}, {'measure': 'Number of patients: Employment status', 'timeFrame': 'Baseline', 'description': 'Patient employment status reported'}, {'measure': 'Number of patients with Initial MS diagnosis', 'timeFrame': 'Baseline', 'description': 'Number of patients with Initial MS diagnosis were reported.'}, {'measure': 'Number of patients with Current MS diagnosis', 'timeFrame': 'Baseline', 'description': 'Number of patients with Current MS diagnosis were reported.'}, {'measure': 'Number of patients with previous disease modifying treatment', 'timeFrame': 'Baseline', 'description': 'Number of patients with previous disease modifying treatment were reported.'}]}, 'conditionsModule': {'keywords': ['Multiple sclerosis (MS),', 'Disease-modifying therapies (DMTs),', 'High efficacy treatments (HETs),', 'Nonhigh efficacy treatments (Non-HETs)'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17971', 'label': 'Results for COMB157G3001 from the Novartis Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This study was a retrospective, non-interventional, cross-sectional, multi-cohort study of patients clinically diagnosed with RMS (RRMS and SPMS). Patients were classified according to the immediate previous treatment in two groups, those who were prescribed with high efficacy treatments (HETs) and those who were prescribed with non-high efficacy treatments (non-HETs). HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod; and non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.', 'detailedDescription': 'The study cohort consisted of RMS patients identified in the Adelphi Real World MS DSP, which was current up until the Q2/2021. The study was using waves VI-IX of the Adelphi DSP dataset.\n\nStudy period: Q1 2017 - Q1 \\& Q2 2021 (waves VI-IX of Adelphi DSP dataset).\n\nIdentification period: Q1 2017 - Q1 \\& Q2 2021 (waves VI-IX of Adelphi DSP dataset).\n\nIndex date: defined as the dates when the surveys were carried out (Q1 2017 - Q1 \\& Q2 2021).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study cohort consisted of RRMS and SPMS patients identified in the Adelphi Real World MS Disease Specific Program (DSP) (2017-2021) with a current and previous treatment at index date, and whose physician decided to switch their treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients included in the database with a diagnosis of RRMS and SPMS.\n* Patients with current treatment at the index date.\n* Patients with previous treatment at the index date.\n* Patients to whom the physician decided to switch the treatment from the previous treatment to current treatment at the index date.\n* Patients (males \\& females) with 18 years or older at index date.\n\nExclusion Criteria:\n\n* Patients included in the database with the diagnosis of primary progressive MS (PPMS).\n* Patients with other major neurological or psychiatric condition, which could potentially hinder the analysis.'}, 'identificationModule': {'nctId': 'NCT05528666', 'briefTitle': 'Risk Perception in Multiple Sclerosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Risk Perception in Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'COMB157G3001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Overall cohort', 'description': 'Included all patients'}, {'label': 'Previous Non-HET', 'description': 'Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.', 'interventionNames': ['Other: Non High Efficacy Therapy (Non-HET)']}, {'label': 'Previous HET', 'description': 'HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.', 'interventionNames': ['Other: High Efficacy Therapy (HET)']}], 'interventions': [{'name': 'High Efficacy Therapy (HET)', 'type': 'OTHER', 'description': 'HET include alemtuzumab, ofatumumab, ocrelizumab, natalizumab, cladribine, fingolimod and ozanimod.', 'armGroupLabels': ['Previous HET']}, {'name': 'Non High Efficacy Therapy (Non-HET)', 'type': 'OTHER', 'description': 'Non-HETs include molecules classified as with moderate or modest efficacy such as: interferons, glatiramer acetate, dimethyl fumarate and teriflunomide.', 'armGroupLabels': ['Previous Non-HET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07936-1080', 'city': 'East Hanover', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8201, 'lon': -74.36487}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}