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

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

Last Update: Nov 14, 2022

See if you pre-qualify

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.

Condition 
Relapsing Multiple Sclerosis
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jul 26, 2022
Completion date 
Jul 30, 2024
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

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.

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 Locations

United Arab Emirates
Novartis Investigative Site
Recruiting
Abu Dhabi,
-
United Arab Emirates
Novartis Investigative Site
Recruiting
Dubai,
-
United Arab Emirates

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]