Lympho-TEC
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Dimethyl fumarate
Kelch-like ECH-associated protein 1 inhibitor
What it measured
Main measures
Time to ALC Reconstitution After DMF Discontinuation
Up to end of study (121 days)
Other measures (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)
Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression
Up to end of study (121 days)
Disability progressionRelapsesPercentage 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
Up to end of study (121 days)
Disability progressionRelapsesTime to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics
Up to end of study (121 days)
Disability progressionRelapsesImmune response
Who could take part
Relapsing MS · 18 and over
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Mar 2021
Main results due
Jun 2021
Finished
Jun 2021
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