Status:
COMPLETED
Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Relapsing Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Brief 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 recruite...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 26 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 11 2024
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT05266469
Start Date
July 26 2022
End Date
November 11 2024
Last Update
July 9 2025
Active Locations (6)
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1
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates
2
Novartis Investigative Site
Sharjah city, United Arab Emirates, United Arab Emirates
3
Novartis Investigative Site
Abu Dhabi, United Arab Emirates, 51900
4
Novartis Investigative Site
Abu Dhabi, United Arab Emirates