Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf

Active, not recruiting

• Conditions: Relapsing Multiple Sclerosis
• Interventions: Other: Ofatumumab; Other: Ocrelizumab

• Registration Number: NCT05266469
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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.

Detailed Description

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.

Index 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).

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Study First Posted: 2022-03-04
• Study Start: 2022-07-26
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-25
• Last Update Posted: 2024-07-26
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 168

Inclusion Criteria

• Males and Females.
• Age 18 to 65 years.
• Confirmed RMS diagnosis as per the 2017 updated McDonald's criteria (Thompson et al., 2018).
• 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).
• 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.
• The patient agreed and provided informed consent on the use of his/her de-identified data.

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Exclusion Criteria

• Patients below 18 years or above 65 years.
• Pregnant females.
• SPMS and/or PPMS patients.
• The patient's refusal to be included in the study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ofatumumab	Ofatumumab	Patients prescribed with Ofatumumab
Ocrelizumab	Ocrelizumab	Patients prescribed with Ocrelizumab

Primary Outcome Measures

Name	Time	Method
Percentage of alcohol intake participants	Baseline	Percentage of alcohol intake participants will be collected
Expanded Disability Status Scale (EDSS)	Baseline	EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS
Number of relapses in the past 12 months	Baseline	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
Percentage of participants by ethnicity	Baseline	Percentage of participants by ethnicity will be collected: * Nationals; * Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other
Percentage of participants by type of coverage	Baseline	Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected
Magnetic Resonance Imaging (MRI) activity	Baseline	number of participants with: * T1-Gd+; * absence of T1-Gd+; * T2 lesions
Time since MS diagnosis	Baseline	Time since Multiple Sclerosis (MS) diagnosis will be provided
Percentage of participants by number of comorbidities	Baseline	Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected
Volume of T2 lesions	Baseline	Volume of T2 lesions will be provided
Baseline ARR (Annualized Relapse Rates)	Baseline	Baseline ARR (Annualized Relapse Rates) will be collected
Percentage of participants with previous DMTs	Baseline	Percentage of participants with previous Disease modifying therapies (DMTs) will be collected
Time from diagnosis to start of treatment	Baseline	Time from diagnosis to start of treatment will be collected
Line of previous DMT treatment	Baseline	Line of previous DMT treatment will be collected
Type of previous DMT	Baseline	Type of previous DMT will be collected: * Any interferon beta; * Glatiramer acetate; * Dimethyl fumarate; * Teriflunomide; * Fingolimod; * Natalizumab; * Cladribine; * Alemtuzumab; * Other B-cell therapy (Rituximab); * Other disease-modifying therapy
Percentage of participants by monthly income	Baseline	Percentage of participants by monthly income (\< 500$, 500-1000$, 1000-5000$, \> 5000$) will be collected
Percentage of patients by frequency preference	Baseline	Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected
Time since first MS symptom	Baseline	Time since first Multiple Sclerosis (MS) symptom will be collected
Number of previous DMT treatment	Baseline	Number of previous DMT treatment will be collected
Percentage of participants with comorbidities	Baseline	Percentage of participants with comorbidities will be collected: * Depression; * Anxiety; * Hypertension; * Hypercholesterolemia; * Chronic lung disease; * Diabetes; * Autoimmune disease; * Migraine; * Cancer (solid/blood); * Neurological Disease; * Cardiovascular Disease; * Other
Percentage of smoking participants	Baseline	Percentage of smoking participants will be collected
Percentage of patients by employment status	Baseline	Percentage of patients by employment status (yes/no) will be collected
Percentage of participants by educational level	Baseline	Percentage of participants by educational level (college level, university level, none, other) will be collected
Percentage of patients by route of administration	Baseline	Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected

Secondary Outcome Measures

Name	Time	Method
Total number of visits	12 months	Total number of visits will be collected
Length of hospital stay	12 months	Length of hospital stay (in days) will be collected
Treatment Satisfaction Questionnaire for Medicines (TSQM)	baseline, 6 months, and 12 months	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
Number and reason of hospitalizations	12 months	Number and reason of hospitalizations will be collected
Reason for out patient department (OPD) visit	12 months	Reason for OPD visit will be collected
proxy costs for each visit	12 months	proxy costs for each visit by type and for all visits will be collected
Number of visits to clinics	12 months	Number of visits to clinics will be collected
Number and reason of ER visits	12 months	Number and reason of Emergency Room (ER) visits will be collected

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇪 Sharjah, United Arab Emirates