A Study to Evaluate the Real-world Experience and Satisfaction Associated With Ofatumumab

A Study Investigating Drivers of Physician and Patient Satisfaction Towards Treatment

The aim of this study is to assess physician and patient satisfaction with ofatumumab using data collected from physicians and their multiple sclerosis (MS) patients in real-world clinical practice across the United Kingdom (UK), France, Germany, Italy, Spain, China, Japan, and Brazil.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 261

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, CH-4056
    • Novartis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Physicians that treat with ofatumumab and MS patients who are receiving ofatumumab, and who are invited to participate following consultation with their physician.

Description

Physician inclusion criteria:

• Physicians must be actively involved in the treatment/management of patients with MS
• Consult with a minimum of 16 MS patients (>5 in Japan and China, >10 in Brazil) per month

Patient inclusion criteria:

Patients for whom physicians complete a Physician Completed Patient Record Form (PRF), and therefore are included in the pool of data for analysis, are based on the following criteria:

• Patients who had a physician-made diagnosis of MS before or at the time of data collection
• Patients must not currently be involved in a clinical trial
• Patients ≥18 years old
• For patients included in the ofatumumab sample, they must have been receiving ofatumumab for >12 months at the time of data collection

Exclusion criteria:

• None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
MS Patient Cohort; Adult patients diagnosed with relapsing multiple sclerosis (RMS) who are receiving treatment with ofatumumab, and who are invited to participate following a consult with their physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Patients by Patient-reported Level of Satisfaction With Current MS Treatment	Patient's level of satisfaction with current treatment categorized as follows: Completely dissatisfied; Moderately dissatisfied; Neither dissatisfied nor satisfied; Moderately satisfied; Completely satisfied; Not on any current treatment for MS	1 Day
Number and Percentage of Patients by Patient-reported MS Status With Their Current Medication Compared to Previous Medication	MS status, as reported by the patient, categorized as follows: Very much better; Much better; A little better; No change; A little worse; Much worse; Very much worse; Don't know; No previous medication taken for MS	1 Day
Number and Percentage of Patients by Physician-reported Patient Response to Current MS Treatment	How well the patient is responding to current treatment rated by the physician from 1 (very poorly) to 5 (very well).	1 Day
Number and Percentage of Patients by Physician-reported Level of Satisfaction With the Patient's Current MS Treatment	Physician's level of satisfaction with patient's current treatment categorized as follows: Completely dissatisfied; Moderately dissatisfied; Neither dissatisfied nor satisfied; Moderately satisfied; Satisfied; Completely satisfied	1 Day
Number and Percentage of Patients Adherent to Current MS Treatment as Reported by the Physician	Adherence, as reported by the physician, categorized as follows: Completely adherent; Mostly adherent; Somewhat adherent; A little adherent; Not at all adherent; Too early in patient's regimen to tell; Don't know	1 Day
Number and Percentage of Patients by Physician-reported Change in Patient Condition Since Initiation of Current MS Treatment	Change in condition, as reported by the physician, categorized as follows: Very much improved; Much improved; A little bit improved; No change; A little bit worse; Much worse; Very much worse	1 Day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and Percentage of Patients by Factors That Influence How the Patient Rates Current Medication Compared to Previous Medication	Factors influencing how patients rate medication include: Frequency of relapses; Impact on symptoms during relapses; MS progression; Convenience (impact on daily routine); Side effects; Route of administration; Frequency of administration; Impact on quality of life (e.g. liveliness, social functioning, perceived wellbeing); No change / No previous medication for MS taken; Don't know	1 Day
Number and Percentage of Patients by Physician-reported Reason for Current MS Treatment Choice		1 Day
Number and Percentage of Patients by Physician-reported Top 5 Reasons for Current MS Treatment Choice		1 Day
Number and Percentage of Patients by Physician-reported Main Areas of Improvement for the Patient's Current MS Treatment		1 Day

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2026
• Primary Completion (Estimated): April 30, 2026
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: March 26, 2026
• First Submitted That Met QC Criteria: March 26, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 27, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Patient satisfaction; Ofatumumab; Satisfaction; Relapsing multiple sclerosis; Physician satisfaction
• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior; Multiple Sclerosis; Personal Satisfaction; Patient Satisfaction
• Other Study ID Numbers: COMB157G2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO