CompletedN/AOther
Impact of Fingolimod Adherence on Outcomes
Sponsored by Novartis Pharmaceuticals
NCT ID
NCT05141669
Target Enrollment
694 participants
Start Date
2020-05-18
Est. Completion
2020-11-20
About This Study
This study was a retrospective observational claims data study of commercial and Medicare Advantage with Part D (MAPD) patients initiating fingolimod.
Conditions Studied
Interventions
- •Fingolimod
Eligibility
Age:18 Years - 85 Years
Healthy Volunteers:No
View full eligibility criteria
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) * By requiring ≥1 medical claim with an MS diagnosis code and ≥2 claims with an NDC for fingolimod, the inclusion criteria essentially incorporated the preferred/overall best performing MS case-finding definition validated by Culpepper et al. The criteria for that definition required at least 3 separate encounters from any of the following: MS-related ambulatory visits, MS-related inpatient stays, and DMT claims during a 12-month period. Slightly higher accuracy was found when a 24-month period was used. Exclusion Criteria: •≥1 pharmacy or medical claim for any MS DMT during the pre-index period
Study Locations (1)
Novartis Investigational Site
East Hanover, New Jersey, United States