Last Update: Jan 18, 2024
Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region
ClinicalTrials.gov Identifier:
NCT05266469
Novartis Reference Number:COMB157GAE01
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All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

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).

Relapsing Multiple Sclerosis
Recruiting
240
Jul 26, 2022
Dec 31, 2024
All
18 Years - 100 Years (Adult, Older Adult)

Interventions

Other

Ocrelizumab

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

Ofatumumab

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

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

Abu Dhabi,51900,United Arab Emirates

Novartis Investigative Site

Recruiting

Abu Dhabi,United Arab Emirates

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