Impact of Fingolimod Adherence on Outcomes

NCT ID: NCT05141669

Last Updated: 2021-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

694 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-11-20

Brief Summary

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This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.

Detailed Description

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The study sample comprised commercial and MAPD enrollees who initiated fingolimod treatment during the identification period of 01 January 2012 through 10 May 2018. The date of the first fingolimod pharmacy claim during the identification period was the index date.

All patients were continuously enrolled in the health plan for 24 months. The 6-month pre-index period, ending the day before the index date, was used to assess patients' clinical characteristics (e.g., comorbid conditions and MS symptoms). The 18-month post-index period started on the index date. The first 6 months of the post-index period (initiation period) were used to assess MS symptoms and adherence. Months 7 - 18 of the post-index period (post-initiation period) were used to measure adherence and outcomes. The 24-month observation period for each patient comprised the 6-month pre-index and 18-month post-index periods.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fingolimod

Participants who initiated fingolimod to treat multiple sclerosis (MS)

Fingolimod

Intervention Type DRUG

Participants who initiated fingolimod to treat multiple sclerosis (MS)

Non-fingolimod Disease Modifying Treatment (DMT)

All patients with ≥ 1 medical or pharmacy claim for a DMT other than fingolimod. Among patients included in the study that those with ≥ 1 pharmacy or medical claim for any MS DMT during pre-index would be excluded.

No interventions assigned to this group

Interventions

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Fingolimod

Participants who initiated fingolimod to treat multiple sclerosis (MS)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old during year of index date with valid gender and geographic information
* Continuous enrollment (CE) in the health plan with medical and pharmacy benefits for ≥6 months (180ii days) before the index date (pre-index period)
* CE with medical and pharmacy benefits for ≥18 months (540 days) beginning on the index date (post-index period)

* All patients had uniform 6-month pre-index and 18-month post-index periods
* ≥1 medical claim with an MS diagnosis codei in any position during the pre-or post-index periods
* ≥1 claim for fingolimod after the index date (i.e., from index date +1 to 539 days post-index)

Exclusion Criteria

•≥1 pharmacy or medical claim for any MS DMT during the pre-index period
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigational Site

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Related Links

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http://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=17883

Results for CFTY720DUS45 from the Novartis Clinical Trials Website

Other Identifiers

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CFTY720DUS45

Identifier Type: -

Identifier Source: org_study_id