Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera

  • STATUS
    Recruiting
  • participants needed
    2000
  • sponsor
    Biogen
Updated on 30 July 2021

Summary

The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation because of lymphopenia, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants.

The secondary objectives of the study are characterization of lymphopenia; characterization of lymphopenia having led to DMF discontinuation treatment; description of the evolution of ALC during DMF treatment; description of discontinuation of DMF treatment; exploration of clinical outcomes in participants with lymphopenia on DMF and/or after DMF discontinuation due to lymphopenia; description of vigilance and participant management overall and in participants with lymphopenia who continued DMF treatment; incidence's assessment of opportunistic or serious infections; investigation of the potential impact of baseline demographic and disease characteristics in risk of developing lymphopenia while on DMF; investigation of the potential impact of baseline demographics on the kinetics of ALC reconstitution upon discontinuation of DMF; investigation of the changes of lymphocyte subtypes in participants on DMF if available.

Description

The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.

Details
Condition Multiple Sclerosis, relapsing-remitting multiple sclerosis, Radiologically Isolated Syndrome, Dermatite Atopique modérée ou grave, multiple sclerosis (ms)
Treatment dimethyl fumarate
Clinical Study IdentifierNCT04756687
SponsorBiogen
Last Modified on30 July 2021

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