Clinical trial NCT06737419: Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
Official title: Real World Effectiveness, Persistence, Tolerability, and Safety of Ofatumumab in Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Clinically Isolated Syndrome
Relapsing-remitting Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2024-12-17
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This was a retrospective, noninterventional cohort study

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.


Eligibility 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)

Primary outcomes:
measure: Number of Patients Categorized by Number of Relapses
timeFrame: Baseline, Month 6, Month 12
measure: Change in Relapse Rate From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
Secondary outcomes:
measure: Age
timeFrame: Baseline
measure: Number of Patients per Demographic Category
timeFrame: Baseline
measure: Mean Duration of Disease
timeFrame: Baseline
measure: Number of Patients by Most Recent Disease Course
timeFrame: Baseline
measure: Number of Patients by Patient Determined Disease Steps (PDDS) Score
timeFrame: Baseline, Month 6, Month 12
measure: Number of Patients Categorized by Comorbidity
timeFrame: Baseline
measure: Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)
timeFrame: Baseline
measure: Number of Prior DMTs
timeFrame: Baseline
measure: Number of Patients who Switched From a DMT to OMB
timeFrame: Baseline
measure: Duration of Time Between Prior DMT and Initiating OMB Treatment
timeFrame: Baseline
measure: Number of Patients by Most Recent Prior DMT
timeFrame: Baseline
measure: Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation
timeFrame: Baseline
measure: Number of Patients by Number of New Brain T2 Lesions
timeFrame: Baseline, Month 6, Month 12
measure: Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions
timeFrame: Baseline, Month 6, Month 12
measure: Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment
timeFrame: From Baseline up to Month 6 and Month 12
measure: Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment
timeFrame: Month 6 and Month 12
measure: Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment
timeFrame: Month 6 and Month 12
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: