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Relapsing Multiple SclerosisNCT05266469

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

An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 6 sites in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Relapsing Multiple Sclerosis
What is being tested?
Ofatumumab and Ocrelizumab
How many people
168 participants
Where
6 sitesUnited Arab Emirates
Study dates
26 Jul 2022to 11 Nov 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United Arab Emirates6 sites

  • Novartis Investigative Site

    Abu Dhabi, 51900

  • Novartis Investigative Site

    Abu Dhabi

  • Novartis Investigative Site

    Al Ain Abu Dhabi, United Arab Emirates

  • Novartis Investigative Site

    Dubai

  • Novartis Investigative Site

    Sharjah city, United Arab Emirates

  • Novartis Investigative Site

    Sharjah city

Other trials in United Arab Emirates

About this study

Official 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

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.

Read the 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).

Being tested
Ofatumumab, Ocrelizumab
Keywords
Relapsing Multiple Sclerosis, RMS, NIS, Gulf Region, Ofatumumab, Ocrelizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OfatumumabOther

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

  • OcrelizumabOther

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

Study groups in NCT05266469
Study groupRoleWhat they receive
OfatumumabPatients prescribed with Ofatumumab
Receives: Other: Ofatumumab
OcrelizumabPatients prescribed with Ocrelizumab
Receives: Other: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expanded Disability Status Scale (EDSS)

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

    Measured: Baseline

  2. Magnetic Resonance Imaging (MRI) activity

    number of participants with:

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

    Measured: Baseline

  3. Volume of T2 lesions

    Volume of T2 lesions will be provided

    Measured: Baseline

  4. 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

    Measured: Baseline

  5. Baseline ARR (Annualized Relapse Rates)

    Baseline ARR (Annualized Relapse Rates) will be collected

    Measured: Baseline

  6. Time since MS diagnosis

    Time since Multiple Sclerosis (MS) diagnosis will be provided

    Measured: Baseline

  7. Time since first MS symptom

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

    Measured: Baseline

  8. Percentage of participants with previous DMTs

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

    Measured: Baseline

  9. Time from diagnosis to start of treatment

    Time from diagnosis to start of treatment will be collected

    Measured: Baseline

  10. Number of previous DMT treatment

    Number of previous DMT treatment will be collected

    Measured: Baseline

  11. Line of previous DMT treatment

    Line of previous DMT treatment will be collected

    Measured: Baseline

  12. 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

    Measured: Baseline

  13. 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

    Measured: Baseline

  14. Percentage of participants by number of comorbidities

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

    Measured: Baseline

  15. Percentage of smoking participants

    Percentage of smoking participants will be collected

    Measured: Baseline

  16. Percentage of alcohol intake participants

    Percentage of alcohol intake participants will be collected

    Measured: Baseline

  17. Percentage of patients by employment status

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

    Measured: Baseline

  18. Percentage of participants by monthly income

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

    Measured: Baseline

  19. Percentage of participants by educational level

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

    Measured: Baseline

  20. 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

    Measured: Baseline

  21. Percentage of patients by frequency preference

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

    Measured: Baseline

  22. Percentage of patients by route of administration

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

    Measured: Baseline

  23. Percentage of participants by type of coverage

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

    Measured: Baseline

Secondary outcomes (8)

  1. 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

    Measured: baseline, 6 months, and 12 months

  2. Total number of visits

    Total number of visits will be collected

    Measured: 12 months

  3. Number of visits to clinics

    Number of visits to clinics will be collected

    Measured: 12 months

  4. Reason for out patient department (OPD) visit

    Reason for OPD visit will be collected

    Measured: 12 months

  5. Number and reason of ER visits

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

    Measured: 12 months

  6. Number and reason of hospitalizations

    Number and reason of hospitalizations will be collected

    Measured: 12 months

  7. Length of hospital stay

    Length of hospital stay (in days) will be collected

    Measured: 12 months

  8. proxy costs for each visit

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start26 Jul 2022
  3. Primary completion11 Nov 2024
  4. Study completion11 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
168 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266469
Sponsor's protocol ID
COMB157GAE01
Status last verified
Jul 2025
First submitted
23 Feb 2022
Last updated
9 Jul 2025
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing Multiple Sclerosis, run by Novartis Pharmaceuticals at 6 sites in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expanded Disability Status Scale (EDSS) (time frame: Baseline). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266469.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.

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