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

NCT04756687

CompletedN/A

Sponsor: Biogen

Conditions: Multiple Sclerosis, Multiple Sclerosis, Relapsing-Remitting

Interventions: Dimethyl fumarate

Countries: France

The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation, in Relapsing-Remitting Multiple Sclerosis (RRMS) participants with lymphopenia. The secondary objectives of the study are characterization of lymphopenia in overall population; characterization of lymphopenia in participant with DMF discontinuation ; description of the evolution of ALC during DMF treatment; description of the time to reach a discontinuation of DMF treatment; exploration of the time to reach clinical outcomes (Expanded Disability Status Scale \[EDSS\] and relapse) according to lymphopenia; description of the event rate of the serious or opportunistic infections in overall population from DMF initiation and according to DMF discontinuation and lymphopenia; description of the event rate of serious and opportunistic infections in overall population from DMF initiation and according to lymphopenia; estimation of the associations between the baseline demographic and clinical characteristics and the risk to reach a lymphopenia; estimation of the associations between the baseline demographics and clinical characteristics and the risk to reach an ALC reconstitution after DMF discontinuation in participants with lymphopenia; and investigation of the changes of absolute cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) count in overall population on DMF if available.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

* Clinical diagnosis of RRMS at DMF initiation
* Minimum of 3 months of continuous treatment with DMF\*
* Initiation of DMF between January 1st, 2016 and December 15th, 2020
* Minimum of 2 ALC assessments:

  1. 1 ALC at DMF initiation (or within 6 months before DMF initiation); or under DMF treatment
  2. 1 ALC before the database extraction (15/06/2021).

     * to avoid the early DMF discontinuations for reasons other than lymphopenia.

Exclusion Criteria:

* Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Locations (32)
  • Amiens, France
  • Besançon, France
  • Bordeaux, France
  • Brest, France
  • Caen, France
  • Clermont-Ferrand, France
  • Dijon, France
  • Grenoble, France
  • Île-de-France - Bicêtre, France
  • Île-de-France - Créteil, France
  • Île-de-France - Poissy St-Germain, France
  • Île-de-France - Pontoise, France
  • Île-de-France - Rothschild, France
  • Île-de-France - Saint-Antoine, France
  • Île-de-France - Saint-Denis, France
  • Île-de-France - Salpêtrière, France
  • Lille, France
  • Limoges, France
  • Lyon, France
  • Marseille, France
  • Montpellier, France
  • Nancy, France
  • Nantes, France
  • Nice, France
  • Nîmes, France
  • Poitiers, France
  • Rennes, France
  • Rouen, France
  • Saint-Etienne, France
  • Strasbourg, France
  • + 2 more on CT.gov