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

Effect of Interferon Beta-1a SC 44 µg Three Times Weekly (Tiw) (Rebif) and Dimethyl Fumarate (DMF, Tecfidera) on Infections and Lymphocytes in Patients 50 Years or Older From a Single Center Chart Review

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).

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Foxboro, Massachusetts, United States, 02035
      • Neurology Center of New England

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The study will include subjects aged 50 years or older with relapsing RRMS, identified from a feasibility assessment conducted at a single center in United States, who were treated with either interferon beta-1a SC 44 micro-gram or dimethyl fumarate between January 1, 2015 to December 31, 2015.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rebif (interferon beta 1a); 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); This study will retrospectively collect the data from the subjects who had been treated with Tecfidera.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With One or More Infections	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of Subjects With One or More Serious Infections	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
Number of Serious Infections per Subject	Baseline, 6 Months, 12 Months
Number of Opportunistic 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
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Counts	Baseline, 6 Months, 12 Months
Cluster of Differentiation 4 (CD4) and Cluster of Differentiation 8 (CD8) Ratio	Baseline, 6 Months, 12 Months
Occurrence of Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline, 6 Months, 12 Months

Collaborators and Investigators

• Sponsor: EMD Serono Research & Development Institute, Inc.
• Collaborators: Merck KGaA, Darmstadt, Germany

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 23, 2017
• Primary Completion (ACTUAL): May 11, 2018
• Study Completion (ACTUAL): May 11, 2018

Study Registration Dates

• First Submitted: September 13, 2017
• First Submitted That Met QC Criteria: September 13, 2017
• First Posted (ACTUAL): September 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Relapsing-Remitting Multiple Sclerosis; Rebif; Dimethyl fumarate; Interferon beta-1a; Tecfidera
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: MS200136_0077