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OpenTrials
Completed

NCT Number: NCT06760624

Effectiveness of Ofatumumab in Real-world Practice

This study used a retrospective single cohort pre-post design on Optum® Clinformatics® Data Mart (CDM) data from 20 August 2019 to 31 December 2023 (study period). Patients with a diagnosis of multiple sclerosis (MS) treated with ofatumumab (OMB) between 20 August 2020 (U.S. Food and Drug Administration [FDA] approval date) and 01 July 2023 (patient identification window) were included in the study population. The date of the first OMB claim within the patient identification window was defined as the index date. Outcomes, including annualized relapse rate (ARR) and MS-related healthcare resource utilization (HCRU), were measured across two distinct periods. The pre-index period was defined as the fixed 12-month period prior to the index date, during which demographic and clinical characteristics were also assessed. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period on 31 December 2023.

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Key information

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

  • Aged 18 years or older as of the index date corresponding to the initial claim for OMB therapy.
  • One claim or more for OMB therapy recorded during the patient identification period (index date = date of the first claim for OMB).
  • One claim or more with a diagnosis of MS (International Classification of Diseases, Tenth Revision [ICD-10] code G35.xx) any time before the index date and up to 6 months after the index date.
  • Continuous healthcare plan enrollment from ≥12 months prior to the index date (pre-index period) to ≥12 months following the index date (post-index period).
  • Persistent use of OMB therapy throughout the post-index period, defined as the absence of a discontinuation of OMB or switch to another MS treatment.

Exclusion criteria

None.

Treatment and study plan

Primary outcomes

  1. Annualized Relapse Rate (ARR) in the Pre-Index Period

    Time frame: 12 months

    The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.

  2. ARR in the Post-index Period

    Time frame: An average of approximately 16 months

    The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another disease modifying therapy [DMT]), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim. The ARR was defined as the number of relapse events per person-year.

  3. Incidence Rate Ratio

    Time frame: An average of approximately 16 months

    Incidence rate ratio was measured to evaluate the change in MS-related ARR in the pre- versus the post-index period.

    The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.

Secondary outcomes

  1. Age

    Time frame: Baseline

  2. Number of Patients per Demographic Category

    Time frame: Baseline

    Demographic categories included:

    • Age Group (18-34, 35-44, 45-54, 55-64, and 65+ years)
    • Gender
    • Race
    • Region
    • Insurance Payer type
    • Year of Index date (2020, 2021, 2022)
  3. Mean Deyo-Charlson Comorbidity Index

    Time frame: Baseline

    Deyo-Charlson Comorbidity Index predicts the ten-year mortality for a patient who may have a range of comorbid conditions. Comorbidity was assessed using the Charlson Comorbidity Index (CCI), categorized as low (0-1) and high (≥2).

  4. Mean Number of Psychiatric Diagnostic Group (PDG) Mental Health Disorders

    Time frame: Baseline

    PDG captures a list of mental health disorders a patient may have at study baseline. The following are the list of PDGs:

    • Adult personality disorders
    • Anxiety disorders
    • Behavioral syndromes
    • Childhood and adolescent psychiatric syndromes
    • Intellectual disabilities
    • Psychiatric disorders with known physiological causes
    • Mood disorders
    • Pervasive disorders
    • Schizophrenia
    • Substance use
  5. Number of Patients Categorized by Top Five Selected Comorbidities

    Time frame: Baseline

    Top five selected comorbidities included osteoarthritis, dyslipidemia, depression, hypertension, and sleep disorders.

  6. Number of Patients Categorized by Top Five MS-related Symptoms and Secondary Conditions

    Time frame: Baseline

    Top five MS-related symptoms and secondary conditions included anxiety, fatigue or malaise, sensory problems, eye symptoms, and urinary tract infection.

  7. Number of Patients Categorized by MS Disability Level

    Time frame: Baseline

    MS disability level was based on observance of Expanded Disability Status Scale (EDSS)-related symptoms and durable medical equipment (DME) use observed in claims data weighted by severity score. Disability levels and definitions were as follows: Severe = Defined as having ≥1 EDSS-related symptom with severity score = 3 in any functional system; Moderate: Defined as having ≥1 EDSS-related symptom with severity score = 2 in any functional system, or having ≥2 functional systems with severity score = 1; Mild: Defined as having only one EDSS-related symptom with severity score = 1 or having no EDSS-related symptoms observed during the measurement period.

  8. Number of Patients Categorized by DMT Used in the Pre-index Period

    Time frame: Baseline

    DMT categories included:

    • Any DMT
    • Low/moderate efficacy therapy
    • High efficacy therapy
    • No DMT
  9. Pre-index Healthcare Resource Utilization (HCRU): Number of MS-related Hospitalizations per Person-year (PPY)

    Time frame: 12 months

    The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim.

  10. Pre-index HCRU: Number of Days of MS-related Hospitalization PPY

    Time frame: 12 months

    The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim.

  11. Pre-index HCRU: Number of MS-related Healthcare Visits PPY

    Time frame: 12 months

    The pre-index period was defined as the fixed 12-month period prior to the index date. The index date was the date of the first OMB claim. MS-related healthcare visits included emergency department visits and outpatient visits.

  12. Post-index HCRU: Number of MS-related Hospitalizations PPY

    Time frame: An average of approximately 16 months

    The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim.

  13. Post-index HCRU: Number of Days of MS-related Hospitalization PPY

    Time frame: An average of approximately 16 months

    The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim.

  14. Post-index HCRU: Number of MS-related Healthcare Visits PPY

    Time frame: An average of approximately 16 months

    The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period. The index date was the date of the first OMB claim. MS-related healthcare visits included emergency department visits and outpatient visits.

  15. Incidence Rate Ratio of MS-related Hospitalizations

    Time frame: An average of approximately 16 months

    Incidence rate ratio was measured to evaluate the change in MS-related hospitalizations in the pre- versus the post-index period.

    The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.

  16. Incidence Rate Ratio of Days of MS-related Hospitalizations

    Time frame: An average of approximately 16 months

    Incidence rate ratio was measured to evaluate the change in days of MS-related hospitalizations in the pre- versus the post-index period.

    The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.

  17. Incidence Rate Ratio of MS-related Emergency Department Visits

    Time frame: An average of approximately 16 months

    Incidence rate ratio was measured to evaluate the change in MS-related emergency department visits in the pre- versus the post-index period.

    The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.

  18. Incidence Rate Ratio of MS-related Outpatient Visits

    Time frame: An average of approximately 16 months

    Incidence rate ratio was measured to evaluate the change in MS-related outpatient visits in the pre- versus the post-index period.

    The index date was the date of the first OMB claim. The pre-index period was defined as the fixed 12-month period prior to the index date. The post-index period was defined as the variable period of ≥6 months after the index date, extending until the earliest between the end of persistent OMB use (defined as last day of OMB supply before a gap of ≥60 days or switch to another DMT), discontinuation of enrollment, or end of study period.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 7, 2025
Registry last updated
Mar 25, 2025

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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