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Completed

NCT Number: NCT05266469

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

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.

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Key information

Conditions

Relapsing Multiple Sclerosis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Al Ain Abu Dhabi, United Arab Emirates

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ofatumumab

Other

There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.

Ocrelizumab

Other

There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Primary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Time frame: Baseline

    EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS

  2. Magnetic Resonance Imaging (MRI) activity

    Time frame: Baseline

    number of participants with:

    • T1-Gd+
    • absence of T1-Gd+
    • T2 lesions

  3. Volume of T2 lesions

    Time frame: Baseline

    Volume of T2 lesions will be provided

  4. Number of relapses in the past 12 months

    Time frame: 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

  5. Baseline ARR (Annualized Relapse Rates)

    Time frame: Baseline

    Baseline ARR (Annualized Relapse Rates) will be collected

  6. Time since MS diagnosis

    Time frame: Baseline

    Time since Multiple Sclerosis (MS) diagnosis will be provided

  7. Time since first MS symptom

    Time frame: Baseline

    Time since first Multiple Sclerosis (MS) symptom will be collected

  8. Percentage of participants with previous DMTs

    Time frame: Baseline

    Percentage of participants with previous Disease modifying therapies (DMTs) will be collected

  9. Time from diagnosis to start of treatment

    Time frame: Baseline

    Time from diagnosis to start of treatment will be collected

  10. Number of previous DMT treatment

    Time frame: Baseline

    Number of previous DMT treatment will be collected

  11. Line of previous DMT treatment

    Time frame: Baseline

    Line of previous DMT treatment will be collected

  12. Type of previous DMT

    Time frame: 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

  13. Percentage of participants with comorbidities

    Time frame: 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

  14. Percentage of participants by number of comorbidities

    Time frame: Baseline

    Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected

  15. Percentage of smoking participants

    Time frame: Baseline

    Percentage of smoking participants will be collected

  16. Percentage of alcohol intake participants

    Time frame: Baseline

    Percentage of alcohol intake participants will be collected

  17. Percentage of patients by employment status

    Time frame: Baseline

    Percentage of patients by employment status (yes/no) will be collected

  18. Percentage of participants by monthly income

    Time frame: Baseline

    Percentage of participants by monthly income (< 500$, 500-1000$, 1000-5000$, > 5000$) will be collected

  19. Percentage of participants by educational level

    Time frame: Baseline

    Percentage of participants by educational level (college level, university level, none, other) will be collected

  20. Percentage of participants by ethnicity

    Time frame: Baseline

    Percentage of participants by ethnicity will be collected:

    • Nationals
    • Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other

  21. Percentage of patients by frequency preference

    Time frame: Baseline

    Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected

  22. Percentage of patients by route of administration

    Time frame: Baseline

    Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected

  23. Percentage of participants by type of coverage

    Time frame: Baseline

    Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected

Secondary outcomes

  1. Treatment Satisfaction Questionnaire for Medicines (TSQM)

    Time frame: 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

  2. Total number of visits

    Time frame: 12 months

    Total number of visits will be collected

  3. Number of visits to clinics

    Time frame: 12 months

    Number of visits to clinics will be collected

  4. Reason for out patient department (OPD) visit

    Time frame: 12 months

    Reason for OPD visit will be collected

  5. Number and reason of ER visits

    Time frame: 12 months

    Number and reason of Emergency Room (ER) visits will be collected

  6. Number and reason of hospitalizations

    Time frame: 12 months

    Number and reason of hospitalizations will be collected

  7. Length of hospital stay

    Time frame: 12 months

    Length of hospital stay (in days) will be collected

  8. proxy costs for each visit

    Time frame: 12 months

    proxy costs for each visit by type and for all visits will be collected

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Mar 4, 2022
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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