Overview
Tecfidera Lymphocyte Chart Review
Status:
Completed
Completed
Trial end date:
2016-02-01
2016-02-01
Target enrollment:
0
0
Participant gender:
All
All
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.Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
BiogenTreatments:
Dimethyl FumarateCriteria
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.