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Tecfidera Lymphocyte Chart Review (REALIZE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02519413
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Drug: dimethyl fumarate

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Study Type : Observational
Actual Enrollment : 483 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Study Start Date : July 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: dimethyl fumarate
    delayed release capsules
    Other Names:
    • DMF; Tecfidera
    • BG00012


Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02519413


Locations
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United States, Alabama
Research site
Homewood, Alabama, United States, 35209
United States, California
Research Site
Newport Beach, California, United States, 92663
United States, Georgia
Research Site
Atlanta, Georgia, United States, 30309
United States, New York
Research Site
Buffalo, New York, United States, 14203
Research Site
Patchogue, New York, United States, 11772
United States, North Carolina
Research Site
Huntersville, North Carolina, United States, 28078
United States, Pennsylvania
Research Site
Philadelphia, Pennsylvania, United States, 19125
United States, Washington
Research Site
Seattle, Washington, United States, 98101
Research Site
Seattle, Washington, United States, 98104
United States, Wisconsin
Research Site
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02519413    
Other Study ID Numbers: 109MS419
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: August 26, 2016
Last Verified: August 2016
Keywords provided by Biogen:
lymphocyte
serious infections
opportunistic infections
Relapsing Forms
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Dimethyl Fumarate
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs