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

Novartis Pharmaceuticals168 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

168

Conditions

Relapsing Multiple Sclerosis

Interventions

OfatumumabOTHER

There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.

OcrelizumabOTHER

There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (6)

Novartis Investigative Site

Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates

Novartis Investigative Site

Sharjah city, United Arab Emirates, United Arab Emirates

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Outcomes

Primary Outcomes

Expanded Disability Status Scale (EDSS)

EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS

Time frame: Baseline

Magnetic Resonance Imaging (MRI) activity

number of participants with: * T1-Gd+ * absence of T1-Gd+ * T2 lesions

Time frame: Baseline

Volume of T2 lesions

Volume of T2 lesions will be provided

Time frame: Baseline

Number of relapses in the past 12 months

Number of relapses in the past 12 months will be collected. Relapse is defined as the occurrence of new symptoms or the worsening of old symptoms that happens during the Multiple Sclerosis course

Time frame: Baseline

Baseline ARR (Annualized Relapse Rates)

Baseline ARR (Annualized Relapse Rates) will be collected

Time frame: Baseline

Time since MS diagnosis

Time since Multiple Sclerosis (MS) diagnosis will be provided

Time frame: Baseline

Time since first MS symptom

Time since first Multiple Sclerosis (MS) symptom will be collected

Time frame: Baseline

Percentage of participants with previous DMTs

Percentage of participants with previous Disease modifying therapies (DMTs) will be collected

Time frame: Baseline

Time from diagnosis to start of treatment

Data from ClinicalTrials.gov

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Novartis Investigative Site

Dubai, United Arab Emirates

Novartis Investigative Site

Sharjah city, United Arab Emirates

Time from diagnosis to start of treatment will be collected

Time frame: Baseline

Number of previous DMT treatment

Number of previous DMT treatment will be collected

Time frame: Baseline

Line of previous DMT treatment

Line of previous DMT treatment will be collected

Time frame: Baseline

Type of previous DMT

Type of previous DMT will be collected: * Any interferon beta * Glatiramer acetate * Dimethyl fumarate * Teriflunomide * Fingolimod * Natalizumab * Cladribine * Alemtuzumab * Other B-cell therapy (Rituximab) * Other disease-modifying therapy

Time frame: Baseline

Percentage of participants with comorbidities

Percentage of participants with comorbidities will be collected: * Depression * Anxiety * Hypertension * Hypercholesterolemia * Chronic lung disease * Diabetes * Autoimmune disease * Migraine * Cancer (solid/blood) * Neurological Disease * Cardiovascular Disease * Other

Time frame: Baseline

Percentage of participants by number of comorbidities

Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected

Time frame: Baseline

Percentage of smoking participants

Percentage of smoking participants will be collected

Time frame: Baseline

Percentage of alcohol intake participants

Percentage of alcohol intake participants will be collected

Time frame: Baseline

Percentage of patients by employment status

Percentage of patients by employment status (yes/no) will be collected

Time frame: Baseline

Percentage of participants by monthly income

Percentage of participants by monthly income (\< 500$, 500-1000$, 1000-5000$, \> 5000$) will be collected

Time frame: Baseline

Percentage of participants by educational level

Percentage of participants by educational level (college level, university level, none, other) will be collected

Time frame: Baseline

Percentage of participants by ethnicity

Percentage of participants by ethnicity will be collected: * Nationals * Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other

Time frame: Baseline

Percentage of patients by frequency preference

Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected

Time frame: Baseline

Percentage of patients by route of administration

Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected

Time frame: Baseline

Percentage of participants by type of coverage

Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected

Time frame: Baseline

Secondary Outcomes

Treatment Satisfaction Questionnaire for Medicines (TSQM)

TSQM, 1.4 Version (1.4) in English and Arabic will be used covering four areas of treatment-related satisfaction, which are safety, convenience, overall satisfaction, and effectiveness. The domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain

Time frame: baseline, 6 months, and 12 months

Total number of visits

Total number of visits will be collected

Time frame: 12 months

Number of visits to clinics

Number of visits to clinics will be collected

Time frame: 12 months

Reason for out patient department (OPD) visit

Reason for OPD visit will be collected

Time frame: 12 months

Number and reason of ER visits

Number and reason of Emergency Room (ER) visits will be collected

Time frame: 12 months

Number and reason of hospitalizations

Number and reason of hospitalizations will be collected

Time frame: 12 months

Length of hospital stay

Length of hospital stay (in days) will be collected

Time frame: 12 months

proxy costs for each visit

proxy costs for each visit by type and for all visits will be collected

Time frame: 12 months