MSFrontier

REALIZE

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)
CompletedRelapsing MSNCT02519413

What it found

No result found

We found no results in the registry or in papers.

This trial finished 10 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

What it measured

Main measures

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

    6 and 12 months

    Immune response

  • Estimated CD4+ count change from baseline following Tecfidera initiation

    6 and 12 months

    Immune response

  • Estimated CD8+ count change from baseline following Tecfidera initiation

    6 and 12 months

    Immune response

Other measures (8)

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

    6 and 12 months

    Immune response

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

    6 and 12 months

    Immune response

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

    6 and 12 months

    Immune response

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

    6 and 12 months

    Immune response

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

    6 and 12 months

    Immune response

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

    6 and 12 months

    Immune response

  • Time to pre-determined lymphocyte counts following Tecfidera initiation

    Up to 12 months

    Immune response

  • Potential predictors of low lymphocyte counts following Tecfidera initiation

    6 and 12 months

    Immune response

Who could take part

Relapsing MS · 18 and over

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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

    Loading reviews and guidelines…

    Linked trials

    • Refers to

      CONFIRM

      Phase 3 · Completed

    • Refers to

      DEFINE

      Phase 3 · Completed

    Links found where a registry record names another trial's registry number.

    Related trials

    History

      1. Started

        Jul 2015

      2. Main results due

        Feb 2016

      3. Finished

        Feb 2016

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