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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Relapsing-Remitting Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rebif (interferon beta 1a)<br>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)<br>This study will retrospectively collect the data from the subjects who had been treated with Tecfidera. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interferon beta-1a, Dimethyl fumarate, Rebif, Tecfidera, Relapsing-Remitting Multiple Sclerosis