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.
Study Type
OBSERVATIONAL
Enrollment
1,507
Administered as specified in the treatment arm.
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
...and 22 more locations
Time to ALC Reconstitution After DMF Discontinuation
Time frame: Up to end of study (121 days)
Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Time frame: 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.
Time frame: Up to end of study (121 days)
Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study
Time frame: Up to end of study (121 days)
Time From DMF Initiation to DMF Discontinuation
Time frame: Up to end of study (121 days)
Percentage of Participants with Discontinuation of DMF Treatment
Time frame: 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).
Time frame: 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
Time frame: Up to end of study (121 days)
Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population
Time frame: 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.
Time frame: 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.
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+ Count
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD8+ Count
Time frame: Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+/CD8+ Ratio
Time frame: Up to end of study (121 days)
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