World Health Organization site
Skip Navigation Links

Please fill this short user satisfaction survey


Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 7 April 2025
Main ID:  NCT05266469
Date of registration: 23/02/2022
Prospective Registration: Yes
Primary sponsor: Novartis Pharmaceuticals
Public title: Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf
Scientific title: Exploring the Characteristics and Profiles of Relapsing Multiple Sclerosis Patients Initiated on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf Region
Date of first enrolment: July 26, 2022
Target sample size: 168
Recruitment status: Completed
URL:  https://clinicaltrials.gov/ct2/show/NCT05266469
Study type:  Observational
Study design:   
Phase: 
Countries of recruitment
Oman United Arab Emirates
Contacts
Name:     Novartis Pharmaceuticals
Address: 
Telephone:
Email:
Affiliation:  Novartis Pharmaceuticals
Key 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All
Health Condition(s) or Problem(s) studied
Relapsing Multiple Sclerosis
Intervention(s)
Other: Ocrelizumab
Other: Ofatumumab
Primary Outcome(s)
Time since MS diagnosis [Time Frame: Baseline]
Percentage of alcohol intake participants [Time Frame: Baseline]
Percentage of participants by number of comorbidities [Time Frame: Baseline]
Baseline ARR (Annualized Relapse Rates) [Time Frame: Baseline]
Magnetic Resonance Imaging (MRI) activity [Time Frame: Baseline]
Percentage of participants by type of coverage [Time Frame: Baseline]
Percentage of participants with previous DMTs [Time Frame: Baseline]
Expanded Disability Status Scale (EDSS) [Time Frame: Baseline]
Line of previous DMT treatment [Time Frame: Baseline]
Number of previous DMT treatment [Time Frame: Baseline]
Percentage of participants by ethnicity [Time Frame: Baseline]
Percentage of patients by employment status [Time Frame: Baseline]
Percentage of patients by route of administration [Time Frame: Baseline]
Time from diagnosis to start of treatment [Time Frame: Baseline]
Time since first MS symptom [Time Frame: Baseline]
Number of relapses in the past 12 months [Time Frame: Baseline]
Percentage of participants by educational level [Time Frame: Baseline]
Percentage of smoking participants [Time Frame: Baseline]
Type of previous DMT [Time Frame: Baseline]
Volume of T2 lesions [Time Frame: Baseline]
Percentage of participants by monthly income [Time Frame: Baseline]
Percentage of participants with comorbidities [Time Frame: Baseline]
Percentage of patients by frequency preference [Time Frame: Baseline]
Secondary Outcome(s)
Total number of visits [Time Frame: 12 months]
Number of visits to clinics [Time Frame: 12 months]
Treatment Satisfaction Questionnaire for Medicines (TSQM) [Time Frame: baseline, 6 months, and 12 months]
Reason for out patient department (OPD) visit [Time Frame: 12 months]
Length of hospital stay [Time Frame: 12 months]
Number and reason of ER visits [Time Frame: 12 months]
Number and reason of hospitalizations [Time Frame: 12 months]
proxy costs for each visit [Time Frame: 12 months]
Secondary ID(s)
COMB157GAE01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history Please fill this short user satisfaction survey