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

Merck KGaA (EMD Serono)

Status: Completed

Conditions: Relapsing-Remitting Multiple Sclerosis

Study type: Observational

Funder types: Industry

Identifiers

NCT03284970

MS200136_0077

Details and patient eligibility

About

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).

Enrollment: 34 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

34 participants in 2 patient groups

Rebif (interferon beta 1a)

Description:

This study will retrospectively collect the data from the subjects who had been treated with Rebif subcutaneously (SC) at a dose of 44 micro-grams three times a week.

Tecfidera (dimethyl fumarate)

Description:

This study will retrospectively collect the data from the subjects who had been treated with Tecfidera.