Clinical trial NCT02519413: Tecfidera Lymphocyte Chart Review
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: lymphocyte
serious infections
opportunistic infections
Relapsing Forms
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2015-08-10
Enrollment: 483
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility 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.

Primary outcomes:
measure: Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Estimated CD4+ count change from baseline following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Estimated CD8+ count change from baseline following Tecfidera initiation
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Raw absolute counts for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Raw absolute counts for additional lymphocyte subsets (other than CD4+ and CD8+)
timeFrame: 6 and 12 months
measure: Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation
timeFrame: 6 and 12 months
measure: Time to pre-determined lymphocyte counts following Tecfidera initiation
timeFrame: Up to 12 months
measure: Potential predictors of low lymphocyte counts following Tecfidera initiation
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Homewood
country: United States
facility: Research site
state: Alabama
city: Newport Beach
country: United States
facility: Research Site
state: California
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Buffalo
country: United States
facility: Research Site
state: New York
city: Patchogue
country: United States
facility: Research Site
state: New York
city: Huntersville
country: United States
facility: Research Site
state: North Carolina
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Seattle
country: United States
facility: Research Site
state: Washington
city: Milwaukee
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: