Multiple Sclerosis Relapses among Copaxone, Glatopa, Gilenya, and Glatiramer Users

Project Title Multiple Sclerosis Relapses among Copaxone, Glatopa, Gilenya, and Glatiramer Users
Date Posted
Tuesday, September 17, 2019
Project ID
cder_mpl1p_wp013
Status
Complete
Deliverables
Description

The goals of this request were to 1) estimate the rate of multiple sclerosis (MS) relapses among Copaxone, Glatopa, Gilenya, and glatiramer users and 2) compare MS relapse algorithms in the Sentinel Distributed Database (SDD). Data from September 21, 2010 to January 31, 2018 from 17 Data Partners contributing to the SDD were included in this report. This request was distributed on June 26, 2018.

Medical Product
Copaxone
Gilenya
Glatopa
glatiramer
Health Outcome
multiple sclerosis relapse
Population / Cohort
Individuals 18-64 years of age
Time Period
September 21, 2010 - January 31, 2018
Assessment Type
Exploratory Analyses
Study Type
Modular Program
Data Sources
Sentinel Distributed Database (SDD)
FDA Center
CDER