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

Completed

• Conditions: Relapsing-Remitting Multiple Sclerosis

• Registration Number: NCT03284970
• Lead Sponsor: EMD Serono Research & Development Institute, Inc.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-23
• Study First Submitted: 2017-09-13
• Study First Submitted QC: 2017-09-13
• Study First Posted: 2017-09-15
• Primary Completion: 2018-05-11
• Study Completion: 2018-05-11
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-03
• Last Update Posted: 2018-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With One or More Infections	Up to 12 months

Secondary Outcome Measures

Name	Time	Method
Number of Opportunistic Infections per Subject	Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio	Baseline, 6 Months, 12 Months
Percentage of Subjects With One or More Serious Infections	Baseline, 6 Months, 12 Months
Number of Serious Infections per Subject	Baseline, 6 Months, 12 Months
Total Lymphocyte Levels	Baseline, 6 Months, 12 Months
Percentage of Subjects With Lymphopenia Grades I, II, III and IV	Baseline, 6 Months, 12 Months
Percentage of Subjects With One or More Opportunistic Infections	Baseline, 6 Months, 12 Months
Number of Infections per Subject	Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts	Baseline, 6 Months, 12 Months
Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline, 6 Months, 12 Months

Trial Locations

Locations (1)

Neurology Center of New England; 🇺🇸 Foxboro, Massachusetts, United States