Study Results
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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COMPLETED
694 participants
OBSERVATIONAL
2020-05-18
2020-11-20
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Fingolimod
Participants who initiated fingolimod to treat multiple sclerosis (MS)
Fingolimod
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)
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
85 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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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
Countries
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Related Links
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Results for CFTY720DUS45 from the Novartis Clinical Trials Website
Other Identifiers
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CFTY720DUS45
Identifier Type: -
Identifier Source: org_study_id