Tecfidera Lymphocyte Chart Review

Multiple Sclerosis Clinical Trial

— REALIZE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02519413
• Other study ID #: 109MS419
• Status: Completed
• Phase: N/A
• First received: July 16, 2015
• Last updated: August 25, 2016
• Start date: July 2015
• Est. completion date: February 2016

Study information

• Verified date: August 2016
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 483
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• dimethyl fumarate
delayed release capsules

Locations

Country	Name	City	State
United States	Research Site	Atlanta	Georgia
United States	Research Site	Buffalo	New York
United States	Research site	Homewood	Alabama
United States	Research Site	Huntersville	North Carolina
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Newport Beach	California
United States	Research Site	Patchogue	New York
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Seattle	Washington
United States	Research Site	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation		6 and 12 months	No
Primary	Estimated CD4+ count change from baseline following Tecfidera initiation		6 and 12 months	No
Primary	Estimated CD8+ count change from baseline following Tecfidera initiation		6 and 12 months	No
Secondary	Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation		6 and 12 months	No
Secondary	Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+)		6 and 12 months	No
Secondary	Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation		6 and 12 months	No
Secondary	Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation		6 and 12 months	No
Secondary	Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation		6 and 12 months	No
Secondary	Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation		6 and 12 months	No
Secondary	Time to pre-determined lymphocyte counts following Tecfidera initiation		Up to 12 months	No
Secondary	Potential predictors of low lymphocyte counts following Tecfidera initiation		6 and 12 months	No