Tecfidera Lymphocyte Chart Review

N/ACompletedNCT02519413

Biogen483 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

483

Conditions

Multiple Sclerosis

Interventions

dimethyl fumarateDRUG

delayed release capsules

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (10)

Research site

Homewood, Alabama, United States

Research Site

Newport Beach, California, United States

Research Site

Atlanta, Georgia, United States

Research Site

Buffalo, New York, United States

Outcomes

Primary Outcomes

Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation

Time frame: 6 and 12 months

Estimated CD4+ count change from baseline following Tecfidera initiation

Time frame: 6 and 12 months

Estimated CD8+ count change from baseline following Tecfidera initiation

Time frame: 6 and 12 months

Secondary Outcomes

Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation

Time frame: 6 and 12 months

Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+)

Time frame: 6 and 12 months

Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation

Time frame: 6 and 12 months

Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation

Time frame: 6 and 12 months

Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation

Time frame: 6 and 12 months

Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation

Time frame: 6 and 12 months

Time to pre-determined lymphocyte counts following Tecfidera initiation

Data from ClinicalTrials.gov

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