NCT02519413

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2015

Shorter than P25 for all trials

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 16, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

August 26, 2016

Status Verified

August 1, 2016

Enrollment Period

7 months

First QC Date

July 16, 2015

Last Update Submit

August 25, 2016

Conditions

Multiple Sclerosis

Keywords

lymphocyteserious infectionsopportunistic infectionsRelapsing Forms

Outcome Measures

Primary Outcomes (3)

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

    6 and 12 months

  • Estimated CD4+ count change from baseline following Tecfidera initiation

    6 and 12 months

  • Estimated CD8+ count change from baseline following Tecfidera initiation

    6 and 12 months

Secondary Outcomes (8)

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

    6 and 12 months

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

    6 and 12 months

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

    6 and 12 months

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

    6 and 12 months

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

    6 and 12 months

  • +3 more secondary outcomes

Interventions

dimethyl fumarateDRUG

delayed release capsules

Also known as: DMF; Tecfidera, BG00012

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Research site

Homewood, Alabama, 35209, United States

Location

Research Site

Newport Beach, California, 92663, United States

Location

Research Site

Atlanta, Georgia, 30309, United States

Location

Research Site

Buffalo, New York, 14203, United States

Location

Research Site

Patchogue, New York, 11772, United States

Location

Research Site

Huntersville, North Carolina, 28078, United States

Location

Research Site

Philadelphia, Pennsylvania, 19125, United States

Location

Research Site

Seattle, Washington, 98101, United States

Location

Research Site

Seattle, Washington, 98104, United States

Location

Research Site

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Multiple SclerosisOpportunistic Infections

Interventions

Dimethyl Fumarate

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesInfections

Intervention Hierarchy (Ancestors)

FumaratesDicarboxylic AcidsAcids, AcyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Medical Director

    Biogen

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2015

First Posted

August 10, 2015

Study Start

July 1, 2015

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

August 26, 2016

Record last verified: 2016-08

Locations

US(10)