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

CompletedRelapsing MSNCT05266469

We could not find results for this trial

I know where the results are

What it found

No result found

We found no results in the registry or in papers.

This trial finished 23 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

Ofatumumab
Ocrelizumab

What it measured

Main measures

Expanded Disability Status Scale (EDSS)
Baseline
Disability progression
Magnetic Resonance Imaging (MRI) activity
Baseline
MRI lesions
Volume of T2 lesions
Baseline
MRI lesions
Number of relapses in the past 12 months
Baseline
Relapses
Baseline ARR (Annualized Relapse Rates)
Baseline
Relapses
Time since MS diagnosis
Baseline
Time since first MS symptom
Baseline
Percentage of participants with previous DMTs
Baseline
Time from diagnosis to start of treatment
Baseline
Number of previous DMT treatment
Baseline
Line of previous DMT treatment
Baseline
Type of previous DMT
Baseline
Immune response
Percentage of participants with comorbidities
Baseline
Mood and sleep
Percentage of participants by number of comorbidities
Baseline
Percentage of smoking participants
Baseline
Percentage of alcohol intake participants
Baseline
Percentage of patients by employment status
Baseline
Percentage of participants by monthly income
Baseline
Percentage of participants by educational level
Baseline
Percentage of participants by ethnicity
Baseline
Percentage of patients by frequency preference
Baseline
Percentage of patients by route of administration
Baseline
Percentage of participants by type of coverage
Baseline

Other measures (8)

Treatment Satisfaction Questionnaire for Medicines (TSQM)
baseline, 6 months, and 12 months
Quality of life (reported by participants)Safety
Total number of visits
12 months
Number of visits to clinics
12 months
Reason for out patient department (OPD) visit
12 months
Number and reason of ER visits
12 months
Number and reason of hospitalizations
12 months
Length of hospital stay
12 months
proxy costs for each visit
12 months

Who could take part

Relapsing MS · 18 to 60

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

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History

Started
Jul 2022
Main results due
Nov 2024
Finished
Nov 2024

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