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

Novartis

Status: Active, not recruiting

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT07504783

COMB157G2021

Details and patient eligibility

About

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.

Enrollment: 261 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

261 participants in 1 patient group

MS Patient Cohort

Description:

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.