Clinical trial NCT05266469: Exploring the Profiles of RMS Patients on Ofatumumab or Ocrelizumab in a Real-World Setting in the Gulf
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing Multiple Sclerosis
RMS
NIS
Gulf Region
Ofatumumab
Ocrelizumab
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-03-04
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and Females aged 18 to 65 years with a confirmed RMS diagnosis, and a provided agreement on the shared informed consent.

Brief summary: 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.

Detailed 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).

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.

Primary outcomes:
measure: Expanded Disability Status Scale (EDSS)
timeFrame: Baseline
measure: Magnetic Resonance Imaging (MRI) activity
timeFrame: Baseline
measure: Volume of T2 lesions
timeFrame: Baseline
measure: Number of relapses in the past 12 months
timeFrame: Baseline
measure: Baseline ARR (Annualized Relapse Rates)
timeFrame: Baseline
measure: Time since MS diagnosis
timeFrame: Baseline
measure: Time since first MS symptom
timeFrame: Baseline
measure: Percentage of participants with previous DMTs
timeFrame: Baseline
measure: Time from diagnosis to start of treatment
timeFrame: Baseline
measure: Number of previous DMT treatment
timeFrame: Baseline
measure: Line of previous DMT treatment
timeFrame: Baseline
measure: Type of previous DMT
timeFrame: Baseline
measure: Percentage of participants with comorbidities
timeFrame: Baseline
measure: Percentage of participants by number of comorbidities
timeFrame: Baseline
measure: Percentage of smoking participants
timeFrame: Baseline
measure: Percentage of alcohol intake participants
timeFrame: Baseline
measure: Percentage of patients by employment status
timeFrame: Baseline
measure: Percentage of participants by monthly income
timeFrame: Baseline
measure: Percentage of participants by educational level
timeFrame: Baseline
measure: Percentage of participants by ethnicity
timeFrame: Baseline
measure: Percentage of patients by frequency preference
timeFrame: Baseline
measure: Percentage of patients by route of administration
timeFrame: Baseline
measure: Percentage of participants by type of coverage
timeFrame: Baseline
Secondary outcomes:
measure: Treatment Satisfaction Questionnaire for Medicines (TSQM)
timeFrame: baseline, 6 months, and 12 months
measure: Total number of visits
timeFrame: 12 months
measure: Number of visits to clinics
timeFrame: 12 months
measure: Reason for out patient department (OPD) visit
timeFrame: 12 months
measure: Number and reason of ER visits
timeFrame: 12 months
measure: Number and reason of hospitalizations
timeFrame: 12 months
measure: Length of hospital stay
timeFrame: 12 months
measure: proxy costs for each visit
timeFrame: 12 months
Other outcomes:
Locations:
city: Muscat
country: Oman
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Al Ain Abu Dhabi
country: United Arab Emirates
facility: Novartis Investigative Site
city: Dubai
country: United Arab Emirates
facility: Novartis Investigative Site
city: Sharjah
country: United Arab Emirates
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: