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

Multiple Sclerosis

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

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source