Retrospective Study to Determine Effect of Rebif and Tecfidera on Infections and Lymphocytes

Completed

Conditions studied: Relapsing-Remitting Multiple Sclerosis

In brief

This study will be a single center, retrospective, pilot study to determine the effect of Rebif (interferon beta-1a) and Tecfidera (dimethyl fumarate) on infections on total lymphocyte counts, grade of lymphopenia, Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) counts and ratios in subjects aged 50 years and above with Relapsing-Remitting Multiple Sclerosis (RRMS).

Key facts

Study ID

NCT03284970

Run by

EMD Serono Research & Development Institute, Inc.

People needed

34

Starts

2017-08-23

Expected to finish

2018-05-11

Last updated by the study team

2018-08-06

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• RRMS subjects who have been treated with interferon beta 1a SC 44 micro-gram thrice a week and dimethyl fumarate in inpatient or outpatient settings during the period from January 1, 2015 to December 31, 2015.
• Subjects with at least one year of laboratory values post-index date to analyze lymphocyte counts, and CD4 and CD8 counts. The date of first blood draw for laboratory tests after January 1, 2015 will be defined as the subject's index date.

You may not qualify if…

• Subjects who have been on treatment for less than 1 year after their index date.

Where it is running

• Neurology Center of New England — Foxborough, Massachusetts, United States

Full record on ClinicalTrials.gov

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