NCT05266469

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

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).

Conditions

• Relapsing Multiple Sclerosis

Interventions

Type	Name	Description
OTHER	Ofatumumab	There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
OTHER	Ocrelizumab	There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Timeline

• Start date: 2022-07-26
• Primary completion: 2024-11-11
• Completion: 2024-11-11
• First posted: 2022-03-04
• Last updated: 2025-07-09

Locations

6 sites across 1 country: United Arab Emirates