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

Relapsing Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05266469
• Other study ID #: COMB157GAE01
• Status: Recruiting
• Start date: July 26, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Relapsing Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Ofatumumab
There is no treatment allocation. Patients administered Ofatumumab by prescription will be enrolled.
• Ocrelizumab
There is no treatment allocation. Patients administered Ocrelizumab by prescription will be enrolled.

Locations

Country	Name	City	State
Oman	Novartis Investigative Site	Muscat
United Arab Emirates	Novartis Investigative Site	Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Al Ain Abu Dhabi
United Arab Emirates	Novartis Investigative Site	Dubai
United Arab Emirates	Novartis Investigative Site	Sharjah

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Oman,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Expanded Disability Status Scale (EDSS)	EDSS: Score 0 to 10, with 0 as "Normal Neurological Exam" and 10 as "Death Due to MS	Baseline
Primary	Magnetic Resonance Imaging (MRI) activity	number of participants with: T1-Gd+; absence of T1-Gd+; T2 lesions	Baseline
Primary	Volume of T2 lesions	Volume of T2 lesions will be provided	Baseline
Primary	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	Baseline
Primary	Baseline ARR (Annualized Relapse Rates)	Baseline ARR (Annualized Relapse Rates) will be collected	Baseline
Primary	Time since MS diagnosis	Time since Multiple Sclerosis (MS) diagnosis will be provided	Baseline
Primary	Time since first MS symptom	Time since first Multiple Sclerosis (MS) symptom will be collected	Baseline
Primary	Percentage of participants with previous DMTs	Percentage of participants with previous Disease modifying therapies (DMTs) will be collected	Baseline
Primary	Time from diagnosis to start of treatment	Time from diagnosis to start of treatment will be collected	Baseline
Primary	Number of previous DMT treatment	Number of previous DMT treatment will be collected	Baseline
Primary	Line of previous DMT treatment	Line of previous DMT treatment will be collected	Baseline
Primary	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	Baseline
Primary	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	Baseline
Primary	Percentage of participants by number of comorbidities	Percentage of participants with 1, 2, 3 and more than 3 comorbidities will be collected	Baseline
Primary	Percentage of smoking participants	Percentage of smoking participants will be collected	Baseline
Primary	Percentage of alcohol intake participants	Percentage of alcohol intake participants will be collected	Baseline
Primary	Percentage of patients by employment status	Percentage of patients by employment status (yes/no) will be collected	Baseline
Primary	Percentage of participants by monthly income	Percentage of participants by monthly income (< 500$, 500-1000$, 1000-5000$, > 5000$) will be collected	Baseline
Primary	Percentage of participants by educational level	Percentage of participants by educational level (college level, university level, none, other) will be collected	Baseline
Primary	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	Baseline
Primary	Percentage of patients by frequency preference	Percentage of patients by frequency preference (daily, weekly, monthly, every 6 months, other) will be collected	Baseline
Primary	Percentage of patients by route of administration	Percentage of patients by route of administration ( PO, IV, IM, SC) will be collected	Baseline
Primary	Percentage of participants by type of coverage	Percentage of participants by type of coverage (Private, Governmental, Self-Payers, Others) will be collected	Baseline
Secondary	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	baseline, 6 months, and 12 months
Secondary	Total number of visits	Total number of visits will be collected	12 months
Secondary	Number of visits to clinics	Number of visits to clinics will be collected	12 months
Secondary	Reason for out patient department (OPD) visit	Reason for OPD visit will be collected	12 months
Secondary	Number and reason of ER visits	Number and reason of Emergency Room (ER) visits will be collected	12 months
Secondary	Number and reason of hospitalizations	Number and reason of hospitalizations will be collected	12 months
Secondary	Length of hospital stay	Length of hospital stay (in days) will be collected	12 months
Secondary	proxy costs for each visit	proxy costs for each visit by type and for all visits will be collected	12 months