Tecfidera Lymphocyte Chart Review (REALIZE)

August 25, 2016 updated by: Biogen

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)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

483

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Research Site
    • California
      • Newport Beach, California, United States, 92663
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Research Site
    • New York
      • Buffalo, New York, United States, 14203
        • Research Site
      • Patchogue, New York, United States, 11772
        • Research Site
    • North Carolina
      • Huntersville, North Carolina, United States, 28078
        • Research Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19125
        • Research Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Research Site
      • Seattle, Washington, United States, 98101
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will be conducted in patients with relapsing forms of multiple sclerosis (MS) who initiated Tecfidera treatment for the first time (treatment naïve) under routine clinical care. For inclusion in the study, patients' charts must have a baseline measurement for absolute lymphocyte count (ALC) and absolute CD4+ or CD8+ count within 6 months prior to Tecfidera initiation, and at least 1 measurement for ALC and absolute CD4+ or CD8+ count while on Tecfidera treatment for at least 6 months. For patients who discontinue Tecfidera, data will be collected for up to 6 months following Tecfidera discontinuation.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

August 7, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Estimate)

August 26, 2016

Last Update Submitted That Met QC Criteria

August 25, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 109MS419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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