Tecfidera Lymphocyte Chart Review

Study Overview
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Brief Summary
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The primary objective of the study is to retrospectively investigate changes in lymphocyte counts and lymphocyte subtypes, with a focus on CD4+ and CD8+ T cells, in participants on Tecfidera therapy for at least 6 months. The secondary objective is to investigate changes in lymphocyte subtypes other than CD4+ and CD8+ T cells.

Official Title
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A Retrospective, Multi-Center, Observational Study to Assess the Effect of Tecfidera® Delayed-Release Capsules on Lymphocyte Subsets in Subjects With Relapsing Forms of Multiple Sclerosis (REALIZE)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: dimethyl fumarate


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Initiated Tecfidera treatment for the first time on or after 27 March 2013 and received at least 6 months of continuous treatment with Tecfidera Clinical diagnosis of a relapsing form of MS A baseline measurement for ALC and absolute CD4+ or CD8+ count within 6 months prior to Tecfidera initiation At least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera therapy for at least 6 months Key Exclusion Criteria: Clinical diagnosis of human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) prior to Tecfidera initiation Participation in DEFINE 109MS301 (NCT00420212) or CONFIRM 109MS302 (NCT00451451) NOTE: Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 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

| Intervention/Treatment |
| --- |
|Drug: dimethyl fumarate|delayed release capsules|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation |  | 6 and 12 months | 
| Estimated CD4+ count change from baseline following Tecfidera initiation |  | 6 and 12 months | 
| Estimated CD8+ count change from baseline following Tecfidera initiation |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation |  | 6 and 12 months | 
| Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+) |  | 6 and 12 months | 
| Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation |  | 6 and 12 months | 
| Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation |  | 6 and 12 months | 
| Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation |  | 6 and 12 months | 
| Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation |  | 6 and 12 months | 
| Time to pre-determined lymphocyte counts following Tecfidera initiation |  | Up to 12 months | 
| Potential predictors of low lymphocyte counts following Tecfidera initiation |  | 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphocyte, serious infections, opportunistic infections, Relapsing Forms