Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
NCT ID: NCT04756687
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1507 participants
OBSERVATIONAL
2021-03-10
2021-06-15
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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All Participants
RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites.
Dimethyl fumarate
Administered as specified in the treatment arm.
Interventions
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Dimethyl fumarate
Administered as specified in the treatment arm.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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Research Site
Amiens, , France
Research Site
Besançon, , France
Research Site
Bordeaux, , France
Research Site
Brest, , France
Research Site
Caen, , France
Research Site
Clermont-Ferrand, , France
Research Site
Dijon, , France
Research Site
Grenoble, , France
Research Site
Île-de-France - Bicêtre, , France
Research Site
Île-de-France - Créteil, , France
Research Site
Île-de-France - Poissy St-Germain, , France
Research Site
Île-de-France - Pontoise, , France
Research Site
Île-de-France - Rothschild, , France
Research Site
Île-de-France - Saint-Antoine, , France
Research Site
Île-de-France - Saint-Denis, , France
Research Site
Île-de-France - Salpêtrière, , France
Research Site
Lille, , France
Research Site
Limoges, , France
Research Site
Lyon, , France
Research Site
Marseille, , France
Research Site
Montpellier, , France
Research Site
Nancy, , France
Research Site
Nantes, , France
Research Site
Nice, , France
Research Site
Nîmes, , France
Research Site
Poitiers, , France
Research Site
Rennes, , France
Research Site
Rouen, , France
Research Site
Saint-Etienne, , France
Research Site
Strasbourg, , France
Research Site
Toulouse, , France
Research Site
Tours, , France
Countries
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References
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de Seze J, Labauge P, Liblau R, Martinez M, Moreau T, Suchet L, Vermersch P, Vukusic S, Mathey G, Michel L, Ciron J, Ruet A, Maillart E, Zephir H, Papeix C, Defer G, Cohen M, Laplaud DA, Berger E, Clavelou P, Thouvenot E, Heinzlef O, Pelletier J, Giannesini C, Casez O, Bourre B, Wahab A, Magy L, Camdessanche JP, Doghri I, Labeyrie C, Hankiewicz K, Neau JP, Pottier C, Dobay P, Li H, Levin S, Gros M, Ruiz M, Rollot F. LymphoTEC: a Retrospective Real-World Study on Lymphocyte Reconstitution After Lymphopenia in Patients with Multiple Sclerosis Treated with Dimethyl Fumarate in France. Adv Ther. 2025 Apr;42(4):1760-1782. doi: 10.1007/s12325-024-03092-5. Epub 2025 Feb 19.
Other Identifiers
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FR-BGT-11758
Identifier Type: -
Identifier Source: org_study_id
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