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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.
The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dimethyl fumarate | Drug | Administered as specified in the treatment arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to ALC Reconstitution After DMF Discontinuation | Up to end of study (121 days) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | This outcome measure will be assessed in subgroup of participants who discontinued DMF in the lymphopenic population. |
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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 ALC at DMF initiation (or within 6 months before DMF initiation); or under DMF treatment
1 ALC before the database extraction (15/06/2021).
Exclusion Criteria:
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All RRMS participants treated with DMF who fulfil the inclusion criteria are eligible to participate in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Biogen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Amiens | France | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39969782 | Derived | 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. |
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In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/
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| 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) |
| Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression | EDSS is based on a standardized neurological exam and focuses on symptoms that commonly occur in multiple sclerosis (MS). Scores range from 0.0 (normal) to 10.0 (death due to MS). | Up to end of study (121 days) |
| Percentage of Participants With Serious or Opportunistic Infections in Overall and According to DMF On-going or not and in Lymphopenic Population | Up to end of study (121 days) |
| Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population | Up to end of study (121 days) |
| Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics | Association between baseline demographic and clinical characteristics like age at DMF initiation, gender, diabetes, smoking habits, first ALC value close to DMF initiation, disease duration at DMF initiation, number of relapses in prior year, baseline EDSS, and any prior DMT will be assessed in this outcome measure. | Up to end of study (121 days) |
| Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics | Association between baseline demographic and clinical characteristics like age at DMF discontinuation, gender, diabetes, smoking habits, last ALC during DMF, disease duration at DMF discontinuation, number of relapses in prior year before DMF initiation, EDSS at DMF discontinuation, DMF duration (overall, up to lymphopenia, after lymphopenia), any prior DMT, and grade of lymphopenia will be assessed in this outcome measure. | Up to end of study (121 days) |
| Percent Change from Baseline in Absolute CD4+ Count | Up to end of study (121 days) |
| Percent Change from Baseline in Absolute CD8+ Count | Up to end of study (121 days) |
| Percent Change from Baseline in Absolute CD4+/CD8+ Ratio | Up to end of study (121 days) |
| 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069462 | Dimethyl Fumarate |
| ID | Term |
|---|---|
| D005650 | Fumarates |
| D003998 | Dicarboxylic Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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