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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.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
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.- 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