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

Novartis

Status: Completed

Conditions: Relapsing Multiple Sclerosis

Treatments: Other: Ofatumumab; Other: Ocrelizumab

Study type: Observational

Funder types: Industry

Identifiers

NCT05266469

COMB157GAE01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 168 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

168 participants in 2 patient groups

Ofatumumab

Description:

Patients prescribed with Ofatumumab

Treatment:

Other: Ofatumumab

Ocrelizumab

Description:

Patients prescribed with Ocrelizumab

Treatment:

Other: Ocrelizumab