Multiple Sclerosis
Conditions
Keywords
lymphocyte, serious infections, opportunistic infections, Relapsing Forms
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.
Interventions
DRUGdimethyl fumarate
delayed release capsules
Sponsors
Biogen
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Raw absolute counts 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 |
| Percentage change from baseline for additional lymphocyte subsets (other than CD4+and CD8+) 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 |
Countries
United States
Outcome results
None listed