Study Description
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. 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).
Interventions
Ocrelizumab
Ofatumumab
Eligibility Criteria
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.
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 Location
Novartis Investigative Site
Recruiting
Muscat,112,Oman
Novartis Investigative Site
Recruiting
Sharjah,United Arab Emirates
Novartis Investigative Site
Recruiting
Abu Dhabi,51900,United Arab Emirates
Worldwide Contacts
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