Tecfidera Lymphocyte Chart Review

Status:	Recruiting
Conditions:	Neurology, Neurology, Multiple Sclerosis
Therapuetic Areas:	Neurology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2015
End Date:	November 2015
Contact:	Biogen
Email:	clinicaltrials@biogen.com

A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE)

The primary objective of the study is to retrospectively investigate changes in lymphocyte
counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on
Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes
in lymphocyte subtypes other than CD4+ and CD8+ T cells.

Inclusion Criteria:

- Initiated Tecfidera treatment for the first time between 27 March 2013 and 30 March
2015, and received at least 6 months of continuous treatment with Tecfidera

- Clinical diagnosis of a relapsing form of MS

- A baseline measurement for ALC and absolute CD4+ or CD8+ count within 6 months prior
to Tecfidera initiation

- At least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera
therapy for at least 6 months

Exclusion Criteria:

- Clinical diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency
syndrome (AIDS) prior to Tecfidera initiation

- Participation in DEFINE 109MS301 (NCT00420212) or CONFIRM 109MS302 (NCT00451451)

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

We found this trial at

sites

Clinical Trial Facility in Huntersville North Carolina

Huntersville, North Carolina 28078

from

Huntersville, NC