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

Last updated: July 7, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

N/A

Condition

Scar Tissue

Memory Loss

Neurologic Disorders

Treatment

Ocrelizumab

Ofatumumab

Clinical Study ID

NCT05266469
COMB157GAE01
  • Ages 18-60
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Males and Females.

  • Age 18 to 65 years.

  • Confirmed RMS diagnosis as per the 2017 updated McDonald's criteria (Thompson etal., 2018).

  • Having their first dose of either drugs during the index period (2019 onwards and upto 1 year since start of the active recruitment period).

  • The decision to initiate either drug should be based on the patient's disease andtaken by the treating physician before the decision of inviting the patient toparticipate in the study.

  • The patient agreed and provided informed consent on the use of his/her de-identifieddata.

Exclusion

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 Design

Total Participants: 168
Treatment Group(s): 2
Primary Treatment: Ocrelizumab
Phase:
Study Start date:
July 26, 2022
Estimated Completion Date:
November 11, 2024

Study 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).

Connect with a study center

  • Novartis Investigative Site

    Muscat, 112
    Oman

    Site Not Available

  • Novartis Investigative Site

    Abu Dhabi, 51900
    United Arab Emirates

    Site Not Available

  • Novartis Investigative Site

    Al Ain Abu Dhabi,
    United Arab Emirates

    Site Not Available

  • Novartis Investigative Site

    Dubai,
    United Arab Emirates

    Site Not Available

  • Novartis Investigative Site

    Sharjah,
    United Arab Emirates

    Site Not Available

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