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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-26

Study Completion Date

2024-11-11

Brief Summary

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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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Detailed Description

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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).

Conditions

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Relapsing Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Ofatumumab

Patients prescribed with Ofatumumab

Ofatumumab

Intervention Type OTHER

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

Ocrelizumab

Patients prescribed with Ocrelizumab

Ocrelizumab

Intervention Type OTHER

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

Interventions

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Ofatumumab

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

Intervention Type OTHER

Ocrelizumab

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

Intervention Type OTHER

Eligibility Criteria

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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.