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OpenTrials
Completed

NCT Number: NCT06737419

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

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Disease Attributes Immune System Diseases Multiple Sclerosis, Chronic Progressive Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Number of Patients Categorized by Number of Relapses

    Time frame: Baseline, Month 6, Month 12

  2. 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

  1. Age

    Time frame: Baseline

  2. Number of Patients per Demographic Category

    Time frame: Baseline

    Demographics included:

    • Gender
    • Race
    • Ethnicity

  3. Mean Duration of Disease

    Time frame: Baseline

  4. Number of Patients by Most Recent Disease Course

    Time frame: 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).

  5. Number of Patients by Patient Determined Disease Steps (PDDS) Score

    Time frame: 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.

  6. Number of Patients Categorized by Comorbidity

    Time frame: Baseline

  7. Number of Patients With no Prior Exposure to Disease Modifying Therapies (DMTs)

    Time frame: Baseline

  8. Number of Prior DMTs

    Time frame: Baseline

  9. Number of Patients who Switched From a DMT to OMB

    Time frame: Baseline

  10. Duration of Time Between Prior DMT and Initiating OMB Treatment

    Time frame: Baseline

  11. Number of Patients by Most Recent Prior DMT

    Time frame: Baseline

    Most recent previous DMTs (in the last 6 months) included high efficacy and medium/low efficacy DMTs.

  12. Number of Patients who Discontinued DMT Prior to OMB Treatment by Reason for Discontinuation

    Time frame: Baseline

  13. Number of Patients by Number of New Brain T2 Lesions

    Time frame: Baseline, Month 6, Month 12

  14. Number of Patients by Number of New Brain Gadolinium Enhancing (GdE) Lesions

    Time frame: Baseline, Month 6, Month 12

  15. Change in Number of New Brain T2 Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

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

  16. Change in Number of New Brain GdE Lesions From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

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

  17. Change in PDDS Scores From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

    Time frame: 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.

  18. Change in Neuro-performance Tests From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

    Time frame: 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).

  19. Change in No Evidence of Disease Activity (NEDA) From Baseline to Month 6 and Month 12 After Initiating OMB Treatment

    Time frame: 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.

  20. Median Change of PDDS From Baseline to Month 6 and Month 12 After Initiation of OMB Treatment

    Time frame: 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.

  21. Number of Patients With 20% or Greater Worsening of Neuro-performance Test Scores After Initiating OMB Treatment

    Time frame: 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).

  22. Number of Patients With 20% or Greater Worsening of PDDS Scores After Initiating OMB Treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 17, 2024
Registry last updated
Dec 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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