Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT05266469
Status:
COMPLETED
Last Update Posted:
2025-07-09
First Post:
2022-02-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Oman']}, 'interventionBrowseModule': {'meshes': [{'id': 'C527517', 'term': 'ofatumumab'}, {'id': 'C533411', 'term': 'ocrelizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 168}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-07', 'studyFirstSubmitDate': '2022-02-23', 'studyFirstSubmitQcDate': '2022-02-23', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Expanded Disability Status Scale (EDSS)', 'timeFrame': 'Baseline', 'description': 'EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS'}, {'measure': 'Magnetic Resonance Imaging (MRI) activity', 'timeFrame': 'Baseline', 'description': 'number of participants with:\n\n* T1-Gd+\n* absence of T1-Gd+\n* T2 lesions'}, {'measure': 'Volume of T2 lesions', 'timeFrame': 'Baseline', 'description': 'Volume of T2 lesions will be provided'}, {'measure': 'Number of relapses in the past 12 months', 'timeFrame': 'Baseline', 'description': 'Number of relapses in the past 12 months will be collected. Relapse is defined as the occurrence of new symptoms or the worsening of old symptoms that happens during the Multiple Sclerosis course'}, {'measure': 'Baseline ARR (Annualized Relapse Rates)', 'timeFrame': 'Baseline', 'description': 'Baseline ARR (Annualized Relapse Rates) will be collected'}, {'measure': 'Time since MS diagnosis', 'timeFrame': 'Baseline', 'description': 'Time since Multiple Sclerosis (MS) diagnosis will be provided'}, {'measure': 'Time since first MS symptom', 'timeFrame': 'Baseline', 'description': 'Time since first Multiple Sclerosis (MS) symptom will be collected'}, {'measure': 'Percentage of participants with previous DMTs', 'timeFrame': 'Baseline', 'description': 'Percentage of participants with previous Disease modifying therapies (DMTs) will be collected'}, {'measure': 'Time from diagnosis to start of treatment', 'timeFrame': 'Baseline', 'description': 'Time from diagnosis to start of treatment will be collected'}, {'measure': 'Number of previous DMT treatment', 'timeFrame': 'Baseline', 'description': 'Number of previous DMT treatment will be collected'}, {'measure': 'Line of previous DMT treatment', 'timeFrame': 'Baseline', 'description': 'Line of previous DMT treatment will be collected'}, {'measure': 'Type of previous DMT', 'timeFrame': 'Baseline', 'description': 'Type of previous DMT will be collected:\n\n* Any interferon beta\n* Glatiramer acetate\n* Dimethyl fumarate\n* Teriflunomide\n* Fingolimod\n* Natalizumab\n* Cladribine\n* Alemtuzumab\n* Other B-cell therapy (Rituximab)\n* Other disease-modifying therapy'}, {'measure': 'Percentage of participants with comorbidities', 'timeFrame': 'Baseline', 'description': 'Percentage of participants with comorbidities will be collected:\n\n* Depression\n* Anxiety\n* Hypertension\n* Hypercholesterolemia\n* Chronic lung disease\n* Diabetes\n* Autoimmune disease\n* Migraine\n* Cancer (solid/blood)\n* Neurological Disease\n* Cardiovascular Disease\n* Other'}, {'measure': 'Percentage of participants by number of comorbidities', 'timeFrame': 'Baseline', 'description': 'Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected'}, {'measure': 'Percentage of smoking participants', 'timeFrame': 'Baseline', 'description': 'Percentage of smoking participants will be collected'}, {'measure': 'Percentage of alcohol intake participants', 'timeFrame': 'Baseline', 'description': 'Percentage of alcohol intake participants will be collected'}, {'measure': 'Percentage of patients by employment status', 'timeFrame': 'Baseline', 'description': 'Percentage of patients by employment status (yes/no) will be collected'}, {'measure': 'Percentage of participants by monthly income', 'timeFrame': 'Baseline', 'description': 'Percentage of participants by monthly income (\\< 500$, 500-1000$, 1000-5000$, \\> 5000$) will be collected'}, {'measure': 'Percentage of participants by educational level', 'timeFrame': 'Baseline', 'description': 'Percentage of participants by educational level (college level, university level, none, other) will be collected'}, {'measure': 'Percentage of participants by ethnicity', 'timeFrame': 'Baseline', 'description': 'Percentage of participants by ethnicity will be collected:\n\n* Nationals\n* Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other'}, {'measure': 'Percentage of patients by frequency preference', 'timeFrame': 'Baseline', 'description': 'Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected'}, {'measure': 'Percentage of patients by route of administration', 'timeFrame': 'Baseline', 'description': 'Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected'}, {'measure': 'Percentage of participants by type of coverage', 'timeFrame': 'Baseline', 'description': 'Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected'}], 'secondaryOutcomes': [{'measure': 'Treatment Satisfaction Questionnaire for Medicines (TSQM)', 'timeFrame': 'baseline, 6 months, and 12 months', 'description': 'TSQM, 1.4 Version (1.4) in English and Arabic will be used covering four areas of treatment-related satisfaction, which are safety, convenience, overall satisfaction, and effectiveness. The domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain'}, {'measure': 'Total number of visits', 'timeFrame': '12 months', 'description': 'Total number of visits will be collected'}, {'measure': 'Number of visits to clinics', 'timeFrame': '12 months', 'description': 'Number of visits to clinics will be collected'}, {'measure': 'Reason for out patient department (OPD) visit', 'timeFrame': '12 months', 'description': 'Reason for OPD visit will be collected'}, {'measure': 'Number and reason of ER visits', 'timeFrame': '12 months', 'description': 'Number and reason of Emergency Room (ER) visits will be collected'}, {'measure': 'Number and reason of hospitalizations', 'timeFrame': '12 months', 'description': 'Number and reason of hospitalizations will be collected'}, {'measure': 'Length of hospital stay', 'timeFrame': '12 months', 'description': 'Length of hospital stay (in days) will be collected'}, {'measure': 'proxy costs for each visit', 'timeFrame': '12 months', 'description': 'proxy costs for each visit by type and for all visits will be collected'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Relapsing Multiple Sclerosis', 'RMS', 'NIS', 'Gulf Region', 'Ofatumumab', 'Ocrelizumab'], 'conditions': ['Relapsing Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'This is a retrospective and prospective, observational mixed-methods (quantitative and qualitative) cohort study of patients who are treated with either Ofatumumab or Ocrelizumab that will be recruited and followed up for one year to collect their profiles across the Gulf countries.', 'detailedDescription': 'This study will be conducted retrospectively (for patients who had their first treatment initiated on either Ofatumumab or Ocrelizumab before study start and from 2019 onwards) and prospectively (for patients who are initiated on either drug during the active recruitment period which spans for one year after the start of the first data collection) using data collected in a standardized manner.\n\nIndex date (baseline): Defined as the date of the first treatment initiated on either Ofatumumab or Ocrelizumab Index period: The patients fulfilling the inclusion criteria will be identified during the recruitment period (01-Jan-2019 to 01-April-2023 or up to 1 year after the start of the active recruitment period).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Males and Females aged 18 to 65 years with a confirmed RMS diagnosis, and a provided agreement on the shared informed consent.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and Females.\n* Age 18 to 65 years.\n* Confirmed RMS diagnosis as per the 2017 updated McDonald's criteria (Thompson et al., 2018).\n* Having their first dose of either drugs during the index period (2019 onwards and up to 1 year since start of the active recruitment period).\n* The decision to initiate either drug should be based on the patient's disease and taken by the treating physician before the decision of inviting the patient to participate in the study.\n* The patient agreed and provided informed consent on the use of his/her de-identified data.\n\nExclusion Criteria:\n\n* Patients below 18 years or above 65 years.\n* Pregnant females.\n* SPMS and/or PPMS patients.\n* The patient's refusal to be included in the study."}, 'identificationModule': {'nctId': 'NCT05266469', 'briefTitle': 'Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region', 'orgStudyIdInfo': {'id': 'COMB157GAE01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ofatumumab', 'description': 'Patients prescribed with Ofatumumab', 'interventionNames': ['Other: Ofatumumab']}, {'label': 'Ocrelizumab', 'description': 'Patients prescribed with Ocrelizumab', 'interventionNames': ['Other: Ocrelizumab']}], 'interventions': [{'name': 'Ofatumumab', 'type': 'OTHER', 'description': 'There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.', 'armGroupLabels': ['Ofatumumab']}, {'name': 'Ocrelizumab', 'type': 'OTHER', 'description': 'There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.', 'armGroupLabels': ['Ocrelizumab']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al Ain Abu Dhabi', 'state': 'United Arab Emirates', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site'}, {'city': 'Sharjah city', 'state': 'United Arab Emirates', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}, {'zip': '51900', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}, {'city': 'Dubai', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.07725, 'lon': 55.30927}}, {'city': 'Sharjah city', 'country': 'United Arab Emirates', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 25.3342, 'lon': 55.41221}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}