Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
Lympho-TEC
A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France
1 other identifier
observational
1,507
1 country
32
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2021
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 12, 2021
CompletedFirst Posted
Study publicly available on registry
February 16, 2021
CompletedStudy Start
First participant enrolled
March 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedOctober 23, 2023
October 1, 2023
3 months
February 12, 2021
October 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Time to ALC Reconstitution After DMF Discontinuation
Up to end of study (121 days)
Secondary Outcomes (13)
Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Up to end of study (121 days)
Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation
Up to end of study (121 days)
Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study
Up to end of study (121 days)
Time From DMF Initiation to DMF Discontinuation
Up to end of study (121 days)
Percentage of Participants with Discontinuation of DMF Treatment
Up to end of study (121 days)
- +8 more secondary outcomes
Study Arms (1)
All Participants
RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites.
Interventions
Eligibility Criteria
All RRMS participants treated with DMF who fulfil the inclusion criteria are eligible to participate in the study.
You may qualify if:
- 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:
- ALC at DMF initiation (or within 6 months before DMF initiation); or under DMF treatment
- ALC before the database extraction (15/06/2021).
- to avoid the early DMF discontinuations for reasons other than lymphopenia.
You may not qualify if:
- Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (32)
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
Related Publications (1)
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.
PMID: 39969782DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 12, 2021
First Posted
February 16, 2021
Study Start
March 10, 2021
Primary Completion
June 15, 2021
Study Completion
June 15, 2021
Last Updated
October 23, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/