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

NCT07504783 | Active Not Recruiting

• 1 other identifier: COMB157G2021
• Study Type: observational
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Keywords

Ofatumumab; Satisfaction; Patient satisfaction; Physician satisfaction; Relapsing multiple sclerosis

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• Number and Percentage of Patients by Factors That Influence How the Patient Rates Current Medication Compared to Previous Medication

  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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• None

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis

Basel, CH-4056, Switzerland

Location

MeSH Terms

Conditions

Multiple Sclerosis; Personal Satisfaction; Patient Satisfaction

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Treatment Adherence and Compliance; Health Behavior

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: January 22, 2026
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)