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Multiple SclerosisREALIZENCT02519413

Tecfidera Lymphocyte Chart Review

An observational study of Multiple Sclerosis, run by Biogen at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
dimethyl fumarate
Type of treatment
Pill or oral medicine
How many people
483 participants
Where
10 sitesUnited States
Study dates
Jul 2015to Feb 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • Research Site

    Atlanta, Georgia, 30309

  • Research Site

    Buffalo, New York, 14203

  • Research site

    Homewood, Alabama, 35209

  • Research Site

    Huntersville, North Carolina, 28078

  • Research Site

    Milwaukee, Wisconsin, 53215

  • Research Site

    Newport Beach, California, 92663

  • Research Site

    Patchogue, New York, 11772

  • Research Site

    Philadelphia, Pennsylvania, 19125

  • Research Site

    Seattle, Washington, 98101

  • Research Site

    Seattle, Washington, 98104

Other trials in United States

About this study

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)

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.

Being tested
dimethyl fumarate
Keywords
lymphocyte, serious infections, opportunistic infections, Relapsing Forms
Medical subject headings
Multiple Sclerosis, Opportunistic Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dimethyl fumarateDrug

    Also called DMF; Tecfidera, BG00012

    delayed release capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

Secondary outcomes (8)

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: 6 and 12 months

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

    Measured: Up to 12 months

  8. Potential predictors of low lymphocyte counts following Tecfidera initiation

    Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startJul 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
483 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02519413
Sponsor's protocol ID
109MS419
Acronym
REALIZE
Status last verified
Aug 2016
First submitted
16 Jul 2015
Last updated
26 Aug 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Biogen at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation (time frame: 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02519413.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2016.

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Tecfidera Lymphocyte Chart Review (NCT02519413) | AzTrials