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

Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region

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.

Study Overview

• Status: Completed
• Conditions: Relapsing Multiple Sclerosis
• Intervention / Treatment: Other: Ofatumumab; Other: Ocrelizumab

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).

• Study Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 51900
    • Novartis Investigative Site
  • Abu Dhabi, United Arab Emirates
    • Novartis Investigative Site
  • Al Ain Abu Dhabi, United Arab Emirates
    • Novartis Investigative Site
  • Dubai, United Arab Emirates
    • Novartis Investigative Site
  • Sharjah, United Arab Emirates
    • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Males and Females aged 18 to 65 years with a confirmed RMS diagnosis, and a provided agreement on the shared informed consent.

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ofatumumab; Patients prescribed with Ofatumumab	Other: Ofatumumab; There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
Ocrelizumab; Patients prescribed with Ocrelizumab	Other: Ocrelizumab; There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expanded Disability Status Scale (EDSS)	EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS	Baseline
Magnetic Resonance Imaging (MRI) activity	number of participants with: T1-Gd+; absence of T1-Gd+; T2 lesions	Baseline
Volume of T2 lesions	Volume of T2 lesions will be provided	Baseline
Number of relapses in the past 12 months	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	Baseline
Baseline ARR (Annualized Relapse Rates)	Baseline ARR (Annualized Relapse Rates) will be collected	Baseline
Time since MS diagnosis	Time since Multiple Sclerosis (MS) diagnosis will be provided	Baseline
Time since first MS symptom	Time since first Multiple Sclerosis (MS) symptom will be collected	Baseline
Percentage of participants with previous DMTs	Percentage of participants with previous Disease modifying therapies (DMTs) will be collected	Baseline
Time from diagnosis to start of treatment	Time from diagnosis to start of treatment will be collected	Baseline
Number of previous DMT treatment	Number of previous DMT treatment will be collected	Baseline
Line of previous DMT treatment	Line of previous DMT treatment will be collected	Baseline
Type of previous DMT	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	Baseline
Percentage of participants with comorbidities	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	Baseline
Percentage of participants by number of comorbidities	Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected	Baseline
Percentage of smoking participants	Percentage of smoking participants will be collected	Baseline
Percentage of alcohol intake participants	Percentage of alcohol intake participants will be collected	Baseline
Percentage of patients by employment status	Percentage of patients by employment status (yes/no) will be collected	Baseline
Percentage of participants by monthly income	Percentage of participants by monthly income (< 500$, 500-1000$, 1000-5000$, > 5000$) will be collected	Baseline
Percentage of participants by educational level	Percentage of participants by educational level (college level, university level, none, other) will be collected	Baseline
Percentage of participants by ethnicity	Percentage of participants by ethnicity will be collected: Nationals; Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other	Baseline
Percentage of patients by frequency preference	Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected	Baseline
Percentage of patients by route of administration	Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected	Baseline
Percentage of participants by type of coverage	Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 11, 2024

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: February 23, 2022
• First Posted (Actual): March 4, 2022

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Relapsing Multiple Sclerosis; Ofatumumab; NIS; Ocrelizumab; RMS; Gulf Region
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Antineoplastic Agents; Immunologic Factors; Physiological Effects of Drugs; Ofatumumab; Ocrelizumab
• Other Study ID Numbers: COMB157GAE01