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

NCT05266469 | Completed

• 1 other identifier: COMB157GAE01
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 6

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.

Conditions

Relapsing Multiple Sclerosis

Keywords

Relapsing Multiple Sclerosis; RMS; NIS; Gulf Region; Ofatumumab; Ocrelizumab

Outcome Measures

Primary Outcomes (23)

• Expanded Disability Status Scale (EDSS)

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

  Baseline

• Magnetic Resonance Imaging (MRI) activity

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

  Baseline

• Volume of T2 lesions

  Volume of T2 lesions will be provided

  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

  Baseline

• Baseline ARR (Annualized Relapse Rates)

  Baseline ARR (Annualized Relapse Rates) will be collected

  Baseline

• Time since MS diagnosis

  Time since Multiple Sclerosis (MS) diagnosis will be provided

  Baseline

• Time since first MS symptom

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

  Baseline

• Percentage of participants with previous DMTs

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

  Baseline

• Time from diagnosis to start of treatment

  Time from diagnosis to start of treatment will be collected

  Baseline

• Number of previous DMT treatment

  Number of previous DMT treatment will be collected

  Baseline

• Line of previous DMT treatment

  Line of previous DMT treatment will be collected

  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

  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

  Baseline

• Percentage of participants by number of comorbidities

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

  Baseline

• Percentage of smoking participants

  Percentage of smoking participants will be collected

  Baseline

• Percentage of alcohol intake participants

  Percentage of alcohol intake participants will be collected

  Baseline

• Percentage of patients by employment status

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

  Baseline

• Percentage of participants by monthly income

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

  Baseline

• Percentage of participants by educational level

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

  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

  Baseline

• Percentage of patients by frequency preference

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

  Baseline

• Percentage of patients by route of administration

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

  Baseline

• Percentage of participants by type of coverage

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

  Baseline

Secondary Outcomes (8)

• Treatment Satisfaction Questionnaire for Medicines (TSQM)

  baseline, 6 months, and 12 months

• 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

Study Arms (2)

Ofatumumab

Patients prescribed with Ofatumumab

Other: Ofatumumab

Ocrelizumab

Patients prescribed with Ocrelizumab

Other: Ocrelizumab

Interventions

Ofatumumab OTHER

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

Ofatumumab

Ocrelizumab OTHER

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

Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (6)

Novartis Investigative Site

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

Location

Novartis Investigative Site

Sharjah city, United Arab Emirates, United Arab Emirates

Location

Novartis Investigative Site

Abu Dhabi, 51900, United Arab Emirates

Location

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Location

Novartis Investigative Site

Dubai, United Arab Emirates

Location

Novartis Investigative Site

Sharjah city, United Arab Emirates

Location

MeSH Terms

Interventions

ofatumumab; ocrelizumab

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: July 26, 2022
• Primary Completion: November 11, 2024
• Study Completion: November 11, 2024
• Last Updated: July 9, 2025

Record last verified: 2025-07

Locations

AE (6)