Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice

Novartis

Status: Completed

Conditions: Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT06737419

COMB157GUS15

Details and patient eligibility

About

This was a retrospective cohort study using the electronic medical record (EMR) database from Cleveland Clinic. The data was analyzed at start of ofatumumab (OMB) therapy (baseline, defined as 6 months prior to OMB initiation) and at 6 or 12 months following initiation of OMB.

Enrollment: 175 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

• Patients who initiated OMB commercially from the time of disease modifying therapy (DMT) approval (August 2020), and
• Aged 18 years or older at index date, and
• Patients who met 2017 McDonald Criteria for clinically definite multiple sclerosis (MS), or
• Patients diagnosed with clinically isolated syndrome (CIS) by Cleveland Clinic MS specialist.

Exclusion criteria: Those who were participating in OMB clinical trials (e.g., ARTIOS, OLIKOS)

Trial design

175 participants in 1 patient group

Ofatumumab Cohort

Description:

Adult patients diagnosed with MS who started OMB therapy from the time of approval (August 2020).