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Completed

NCT Number: NCT06459232

Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With Disease-Modifying Therapies

This retrospective, observational cohort study used administrative claims data contained in the International Business Machines (IBM)® Truven Marketscan® Research Databases to describe demographic, clinical, and treatment characteristics in patients with multiple sclerosis (MS) who were initiated on siponimod, and other Food and Drug Administration (FDA)-approved disease-modifying therapies (DMTs). The study time period was from March 2018 through June 2020 (most recent available data) and included a 1-year baseline period and a variable-length follow-up period (a minimum of 6 months follow-up required for post-index outcomes). The index date was defined as the date of the first claim for siponimod or other MS-specific treatment on or after March 2019.

The data analysis was performed on a combination of early view and standard view data. The initial data analysis was from Standard Marketscan data used for patients with index data prior to the year 2019. Both standard view and early view data were used for patients indexed after January 1, 2019. The early view data provided additional visibility as it contains an additional 2 quarters of data compared to standard data.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Pharmaceuticals

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

  • With 1 or more claims of siponimod or MS-related FDA-approved DMT during the index calendar year. The date of first claim was the index date.
  • With 1 or more MS diagnosis for 12 months prior to the index date [inclusive].
  • Were continuously enrolled in pharmacy and medical benefits for 12 months prior to the index date [inclusive].
  • Include patients who were 18 years or older on the index date.
  • Include patients continuously enrolled in pharmacy and medical benefits from the index date [inclusive] to 6 months/12 months post-index date.

Exclusion criteria

  • Patients with 1 or more claims of index drug within 12 months prior to index date.

Treatment and study plan

Primary outcomes

  1. Number of Patients with a Minimum of 6 Months Follow-up by Disease-Modifying Therapy (DMT) Use

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)

  2. Number of Patients with a Minimum of 12 Months Follow-up by DMT Use

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim (index date)

Secondary outcomes

  1. Mean Age

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  2. Number of Patients with a Minimum of 6 Months Follow-up by Age Group

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

    Age group categories included:

    • 18-34 years
    • 35-44 years
    • 45-54 years
    • 55-64 years
    • 65+ years

  3. Number of Patients with a Minimum of 12 Months Follow-up by Age Group

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

    Age group categories included:

    • 18-34 years
    • 35-44 years
    • 45-54 years
    • 55-64 years
    • 65+ years

  4. Number of Patients with a Minimum of 6 months Follow-up by Gender

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  5. Number of Patients with a Minimum of 12 months Follow-up by Gender

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  6. Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  7. Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  8. Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  9. Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  10. Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  11. Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type

    Time frame: Index date, defined as the date of the first claim for siponimod or MS-specific therapy

  12. Percentage of Patients with MS Relapses

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

  13. Mean Charlson Comorbidity Index (CCI) Score

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

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

  14. Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

    Disability levels included: No symptoms, Mild, Moderate, and Severe.

  15. Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

    Disability levels included: No symptoms, Mild, Moderate, and Severe.

  16. Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

  17. Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

  18. Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

  19. Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT

    Time frame: Baseline, defined as the 12 months prior to the first observed MS therapy claim

  20. Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up

    Time frame: 6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)

    Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.

  21. Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up

    Time frame: 12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)

    Proportion of days covered was calculated as the number of days in the follow-up period that the patient had index medication on hand, divided by the total number of days in the follow-up period.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

Baseline Characteristics, Adherence, and Persistence Among Multiple Sclerosis Patients Treated With FDA-approved Disease-Modifying Therapies

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 14, 2024
Registry last updated
Jun 14, 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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