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

Novartis Pharmaceuticals1 site in 1 country175 target enrollmentJune 9, 2021

ConditionsMultiple Sclerosis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Multiple Sclerosis
Sponsor: Novartis Pharmaceuticals
Enrollment: 175
Locations: 1
Primary Endpoint: Number of Patients Categorized by Number of Relapses
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 9, 2021

End Date

February 5, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Number of Patients Categorized by Number of Relapses

Time Frame: Baseline, Month 6, Month 12

Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

Time Frame: From Baseline up to Month 6 and Month 12

Secondary Outcomes

Age(Baseline)
Number of Patients per Demographic Category(Baseline)
Mean Duration of Disease(Baseline)
Number of Patients by Most Recent Disease Course(Baseline)
Number of Patients by Patient Determined Disease Steps (PDDS) Score(Baseline, Month 6, Month 12)
Number of Patients Categorized by Comorbidity(Baseline)
Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)(Baseline)
Number of Prior DMTs(Baseline)
Number of Patients who Switched From a DMT to OMB(Baseline)
Duration of Time Between Prior DMT and Initiating OMB Treatment(Baseline)
Number of Patients by Most Recent Prior DMT(Baseline)
Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation(Baseline)
Number of Patients by Number of New Brain T2 Lesions(Baseline, Month 6, Month 12)
Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions(Baseline, Month 6, Month 12)
Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment(From Baseline up to Month 6 and Month 12)
Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment(From Baseline up to Month 6 and Month 12)
Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment(Month 6 and Month 12)
Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment(Month 6 and Month 12)