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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT06737419
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-06-09
• Primary Completion: 2024-02-05
• Study Completion: 2024-02-05
• Status Verified: 2024-12
• Study First Submitted: 2024-12-12
• Study First Submitted QC: 2024-12-12
• Last Update Submitted: 2024-12-12
• Study First Posted: 2024-12-17
• Last Update Posted: 2024-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of Patients Categorized by Number of Relapses	Baseline, Month 6, Month 12
Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment	From Baseline up to Month 6 and Month 12

Secondary Outcome Measures

Name	Time	Method
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	Most recent previous DMTs (in the last 6 months) included high efficacy and medium/low efficacy DMTs.
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
Mean Duration of Disease	Baseline
Number of Patients by Most Recent Disease Course	Baseline	Most recent disease course (in the last 6 months) included relapsing-remitting MS (RRMS)/clinically isolated syndrome (CIS), secondary progressive MS (SPMS), and primary progressive MS (PPMS).
Number of Patients by Patient Determined Disease Steps (PDDS) Score	Baseline, Month 6, Month 12	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Age	Baseline
Number of Patients per Demographic Category	Baseline	Demographics included: * Gender; * Race; * Ethnicity
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	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
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	Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).
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	When available, disability progression measures were calculated for patients. No evidence of disease activity (NEDA-2) status was defined and measured as the absence of clinical relapses and new/enlarging T2 and GdE lesions. NEDA-3 status was defined as components of NEDA-2 and absence of PDDS score worsening. NEDA-2 and NEDA-3 were only evaluated in patients who had all relevant parameters available for review.
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	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.
Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment	Month 6 and Month 12	Neuro-performance measures included four assessments, cognitive assessment through the processing speed test (PST), upper extremity motor function through the manual dexterity test (MDT), lower extremity function through the walking speed test (WST), and vision assessment through the contrast sensitivity test (CST). PST and CST were scored based on the number of correct responses (with a higher score representing better performance), while MDT and WST were measured based on time to completion (with a lower score representing better performance).
Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment	Month 6 and Month 12	The PDDS is a standardized rating scale which is a self-assessment scale of functional disability in MS patients primarily based on ambulation. The questionnaire contained 1 question which was scored ranging from 0 = Normal; 1 = Mild disability; 2 = Moderate disability; 3 = Gait disability; 4 = Early cane; 5 = Late cane; 6 = Bilateral support; and 7 = Wheelchair bound.

Trial Locations

Locations (1)

Novartis; 🇺🇸 East Hanover, New Jersey, United States