Tecfidera Lymphocyte Chart Review
Completed
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02519413
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 483
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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimated CD8+ count change from baseline following Tecfidera initiation 6 and 12 months Estimated CD4+ count change from baseline following Tecfidera initiation 6 and 12 months Estimated absolute lymphocyte count (ALC) change from baseline following Tecfidera initiation 6 and 12 months
- Secondary Outcome Measures
Name Time Method Change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation 6 and 12 months Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) following Tecfidera initiation 6 and 12 months 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 Percentage change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation 6 and 12 months Time to pre-determined lymphocyte counts following Tecfidera initiation Up to 12 months Potential predictors of low lymphocyte counts following Tecfidera initiation 6 and 12 months Change from baseline for leukocyte, lymphocyte, CD4+/CD8+ ratio following Tecfidera initiation 6 and 12 months
Trial Locations
- Locations (2)
Research site
🇺🇸Homewood, Alabama, United States
Research Site
🇺🇸Milwaukee, Wisconsin, United States