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Without the participation of people with MS, it would be impossible to develop new and better therapies and other interventions.

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05266469
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Novartis Pharmaceuticals
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Novartis Pharmaceuticals
Principal Investigator Affiliation	Novartis Pharmaceuticals
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Oman, United Arab Emirates
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Relapsing Multiple Sclerosis

Additional Details

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).

Arms & Interventions

Arms

: Ofatumumab

Patients prescribed with Ofatumumab

: Ocrelizumab

Patients prescribed with Ocrelizumab

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.