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OpenTrials
Completed

NCT Number: NCT05576779

Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis.

This was a retrospective cohort study utilizing secondary data from IQVIA's open source pharmacy claims database (i.e., IQVIA LRx) selecting patients with prescription claims for ofatumumab or other DMTs of interest.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System COVID-19 Coronaviridae Infections Coronavirus Infections Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Lung Diseases Nervous System Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site

East Hanover, New Jersey, 07936-1080, United States

About this study

The date of first ofatumumab prescription claim or other DMT of interest was defined as the index date. No post-index requirements were imposed.

Patients were linked to IQVIA's open source medical claims databases (Dx) to obtain patient clinical characteristics.

The initial data were extracted in October 2020. The data and results were refreshed in April 2021 and July 2021 to allow for assessment of changes in characteristics at 6 and 9 months post-launch.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with ≥ 1 prescription for ofatumumab in the LRx/Dx database were included. The date of the first observed prescription within the index window served as the index date.

-. Patients with a diagnosis of COVID-19 or a COVID-19 vaccination any time during the study period.

  • Patients with linkage to the Dx database.

Exclusion criteria

  • No exclusion criteria were applied to patients in the study.

Treatment and study plan

Ofatunumab

Other

All eligible patients with at least 1 claim for ofatumumab observed during the index period were included in the ofatumumab cohort

Primary outcomes

  1. Proportion of patients initiating ofatumumab based on DMT use

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    The primary measure was pre-index treatment status of patients initiating ofatumumab, measured as proportion (n, %) of DMT-naïve and DMT-experienced patients among patients initiating ofatumumab based on DMT use in the 12-month pre-index period.

Secondary outcomes

  1. Age

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Age information was reported

  2. Gender

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Gender information was reported

  3. Number of patients: Geographic region

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Northeast, Midwest, South, West, Unknown

  4. Number of patients: State level (Geographic region)

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    The geographical heat map of ofatumumab utilization at the state level was presented.

  5. Number of patients: Insurance type

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Cash, Commercial, Medicare, Medicare Part D, Medicaid, Unknown

  6. Number of patients: Payer

    Time frame: Index date, defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    CVS, Aetna etc

  7. Follow-up time

    Time frame: Variable Post-index period, where index date was defined as date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Ofatumumab persistence was assessed over the variable follow-up time.

  8. Number of patients: Pre-index Charlson comorbidity index (CCI)

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

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

  9. Number of patients: Pre-index comorbidities

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with list of comorbidities were reported

  10. Number of patients with a relapse in inpatient settings

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with MS relapses were reported

  11. Number of patients with a relapse in outpatient settings

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with MS relapses were reported

  12. Number of relapses in all patients

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with MS relapses were reported

  13. Number of relapses in patients with at least 1 relapse

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with MS relapses were reported

  14. Claims-Based Disability Score

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Pre-index MS-related symptoms and secondary conditions (n, %) based on a Claims-Based Disability Score (e.g., sensory problems, eye symptoms, pyramidal symptoms, bladder/bowel symptoms, fatigue/malaise, muscular weakness, durable medical equipment utilization.

  15. Number of pre-index Brain and Spinal MRI scans

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Categorized as: No MRI, 1, 2, 3+

  16. Number of patients: Hepatitis B virus screening

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Yes/No

  17. Number of patients: Quantitative serum immunoglobulin screening

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Yes/No

  18. Number of patients: Pre-index flu shot

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Yes/No

  19. Number of patients: Post-index flu shot

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Yes/No

  20. Pre-index: Number of patients with COVID-19 diagnosis

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Yes/No

  21. Post-index: Number of patients with COVID-19 diagnosis

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Yes/No

  22. Days between COVID-19 diagnosis and initiation of ofatumumab

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Days between COVID-19 diagnosis and initiation of ofatumumab were reported

  23. Pre-index: Number of patients with COVID-19 vaccination

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Yes/No

  24. Post-index: Number of patients with COVID-19 vaccination

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Yes/No

  25. Days between COVID-19 vaccination and initiation of ofatumumab

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Days between COVID-19 vaccination and initiation of ofatumumab were reported.

  26. Proportion of patients with steroid use or antihistamine as pre-medication with ofatumumab first dose

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    E.g. diphenhydramine, dexamethasone and other steroids. pre-medication was defined as medication observed within two days of ofatumumab initiation.

  27. Pre-index HCRU: Number of patients with an inpatient visit

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with an inpatient visits were reported to report the pre-index healthcare resource utilization

  28. Pre-index HCRU: Number of patients with an ED visit

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with an ED visit were reported to report the pre-index healthcare resource utilization

  29. Pre-index HCRU: Number of patients with an outpatient visit

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with an outpatient visit were reported to report the pre-index healthcare resource utilization

  30. Pre-index HCRU: Number of patients with a pharmacy claim

    Time frame: 12-months prior to index date, where index date was defined as the date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts)

    Number of patients with a pharmacy claim were reported to report the pre-index healthcare resource utilization

  31. Post-index HCRU: Number of patients with an inpatient visit

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Number of patients with an inpatient visits were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

  32. Post-index HCRU: Number of patients with an ED visit

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Number of patients with an ED visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

  33. Post-index HCRU: Number of patients with an outpatient visit

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Number of patients with an outpatient visit were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

  34. Post-index HCRU: Number of patients with a pharmacy claim

    Time frame: Variable Post-index period, where index date was defined as Date of first ofatumumab claim (or other DMT of interest for non-ofa cohorts) (01/08/2019 - 31/05/2021)

    Number of patients with a pharmacy claim were reported to report the post-index healthcare resource utilization accrued while on ofatumumab

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Characterization of Early Patients Initiating Ofatumumab for Treatment of Multiple Sclerosis in the Real-World

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 13, 2022
Registry last updated
Nov 8, 2022

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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