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Completed

NCT Number: NCT02519413

Tecfidera Lymphocyte Chart Review

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Infections Nervous System Diseases Opportunistic Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research site, Homewood, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dimethyl fumarate

Drug

delayed release capsules

Other names: DMF; Tecfidera, BG00012

Primary outcomes

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

    Time frame: 6 and 12 months

  2. Estimated CD4+ count change from baseline following Tecfidera initiation

    Time frame: 6 and 12 months

  3. Estimated CD8+ count change from baseline following Tecfidera initiation

    Time frame: 6 and 12 months

Secondary outcomes

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

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

    Time frame: 6 and 12 months

  7. Time to pre-determined lymphocyte counts following Tecfidera initiation

    Time frame: Up to 12 months

  8. Potential predictors of low lymphocyte counts following Tecfidera initiation

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study 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)

Acronym: REALIZE

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 10, 2015
Registry last updated
Aug 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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