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

NCT06459232 | Completed

• 1 other identifier: CBAF312AUS16
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

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

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

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

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

Secondary Outcomes (21)

• Mean Age

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

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

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

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

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

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

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

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

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

Study Arms (1)

Multiple Sclerosis (MS) Cohort

Adult MS patients with at least 1 claim of siponimod or an MS-related FDA-approved DMT.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This was a retrospective, noninterventional cohort study.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2024
• First Posted: June 14, 2024
• Study Start: November 19, 2020
• Primary Completion: December 17, 2021
• Study Completion: December 17, 2021
• Last Updated: June 14, 2024

Record last verified: 2024-06

Locations

US (1)