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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05266469

Collaborator

(none)

240

Enrollment

Location

24.1

Anticipated Duration (Months)

9.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Relapsing Multiple Sclerosis	Other: Ofatumumab Other: Ocrelizumab

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Cohort

Time Perspective:

Other

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

Actual Study Start Date :

Jul 26, 2022

Anticipated Primary Completion Date :

Jul 30, 2024

Anticipated Study Completion Date :

Jul 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Ofatumumab Patients prescribed with Ofatumumab	Other: Ofatumumab There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
Ocrelizumab Patients prescribed with Ocrelizumab	Other: Ocrelizumab There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Arm

Intervention/Treatment

Ofatumumab

Patients prescribed with Ofatumumab

Other: Ofatumumab

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

Ocrelizumab

Patients prescribed with Ocrelizumab

Other: Ocrelizumab

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

Outcome Measures

Primary Outcome Measures

Expanded Disability Status Scale (EDSS) [Baseline]
EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS
Magnetic Resonance Imaging (MRI) activity [Baseline]
number of participants with: T1-Gd+ absence of T1-Gd+ T2 lesions
Volume of T2 lesions [Baseline]
Volume of T2 lesions will be provided
Number of relapses in the past 12 months [Baseline]
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
Baseline ARR (Annualized Relapse Rates) [Baseline]
Baseline ARR (Annualized Relapse Rates) will be collected
Time since MS diagnosis [Baseline]
Time since Multiple Sclerosis (MS) diagnosis will be provided
Time since first MS symptom [Baseline]
Time since first Multiple Sclerosis (MS) symptom will be collected
Percentage of participants with previous DMTs [Baseline]
Percentage of participants with previous Disease modifying therapies (DMTs) will be collected
Time from diagnosis to start of treatment [Baseline]
Time from diagnosis to start of treatment will be collected
Number of previous DMT treatment [Baseline]
Number of previous DMT treatment will be collected
Line of previous DMT treatment [Baseline]
Line of previous DMT treatment will be collected
Type of previous DMT [Baseline]
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
Percentage of participants with comorbidities [Baseline]
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
Percentage of participants by number of comorbidities [Baseline]
Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected
Percentage of smoking participants [Baseline]
Percentage of smoking participants will be collected
Percentage of alcohol intake participants [Baseline]
Percentage of alcohol intake participants will be collected
Percentage of patients by employment status [Baseline]
Percentage of patients by employment status (yes/no) will be collected
Percentage of participants by monthly income [Baseline]
Percentage of participants by monthly income (< 500$, 500-1000$, 1000-5000$, > 5000$) will be collected
Percentage of participants by educational level [Baseline]
Percentage of participants by educational level (college level, university level, none, other) will be collected
Percentage of participants by ethnicity [Baseline]
Percentage of participants by ethnicity will be collected: Nationals Non-Nationals, other Indian Bangladeshi Pakistani Egyptian Filipino Iranian Nepali Sri Lankan Chinese Other
Percentage of patients by frequency preference [Baseline]
Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected
Percentage of patients by route of administration [Baseline]
Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected
Percentage of participants by type of coverage [Baseline]
Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected

Secondary Outcome Measures

Treatment Satisfaction Questionnaire for Medicines (TSQM) [baseline, 6 months, and 12 months]
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
Total number of visits [12 months]
Total number of visits will be collected
Number of visits to clinics [12 months]
Number of visits to clinics will be collected
Reason for out patient department (OPD) visit [12 months]
Reason for OPD visit will be collected
Number and reason of ER visits [12 months]
Number and reason of Emergency Room (ER) visits will be collected
Number and reason of hospitalizations [12 months]
Number and reason of hospitalizations will be collected
Length of hospital stay [12 months]
Length of hospital stay (in days) will be collected
proxy costs for each visit [12 months]
proxy costs for each visit by type and for all visits will be collected

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.