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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06459232
• Other study ID #: CBAF312AUS16
• Status: Completed
• Start date: November 19, 2020
• Est. completion date: December 17, 2021

Study information

• Verified date: June 2024
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Novartis Pharmaceuticals	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Mean Age		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 6 Months Follow-up by Age Group	Age group categories included: 18-34 years; 35-44 years; 45-54 years; 55-64 years; 65+ years	Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 12 Months Follow-up by Age Group	Age group categories included: 18-34 years; 35-44 years; 45-54 years; 55-64 years; 65+ years	Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	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
Secondary	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
Secondary	Number of Patients with a Minimum of 6 Months Follow-up by Geographical Region		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 12 Months Follow-up by Geographical Region		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 6 Months Follow-up by Insurance Plan Type		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 12 Months Follow-up by Insurance Plan Type		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 6 Months Follow-up by Health Plan Type		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Number of Patients with a Minimum of 12 Months Follow-up by Health Plan Type		Index date, defined as the date of the first claim for siponimod or MS-specific therapy
Secondary	Percentage of Patients with MS Relapses		Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Mean Charlson Comorbidity Index (CCI) Score	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).	Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Percentage of Patients with a Minimum of 6 Months Follow-up by Disability Level	Disability levels included: No symptoms, Mild, Moderate, and Severe.	Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Percentage of Patients with a Minimum of 12 Months Follow-up by Disability Level	Disability levels included: No symptoms, Mild, Moderate, and Severe.	Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Percentage of Patients with a Minimum of 6 Months Follow-up by Most Observed Comorbidities		Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Percentage of Patients with a Minimum of 12 Months Follow-up by Most Observed Comorbidities		Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Number of Patients with a Minimum of 6 Months Follow-up by Type of Prior Disease-Modifying Therapy (DMT)		Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Number of Patients with a Minimum of 12 Months Follow-up by Type of Prior DMT		Baseline, defined as the 12 months prior to the first observed MS therapy claim
Secondary	Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 6 Months Follow-up	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.	6 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)
Secondary	Mean Proportion of Days Covered (Adherence) for Patients with a Minimum of 12 Months Follow-up	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.	12 months post-index date (defined as date of the first claim for siponimod or other MS-specific treatment)