- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04756687
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
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Amiens, France
- Research Site
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Besançon, France
- Research Site
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Bordeaux, France
- Research Site
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Brest, France
- Research Site
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Caen, France
- Research Site
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Clermont-Ferrand, France
- Research Site
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Dijon, France
- Research Site
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Grenoble, France
- Research Site
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Lille, France
- Research Site
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Limoges, France
- Research Site
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Lyon, France
- Research Site
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Marseille, France
- Research Site
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Montpellier, France
- Research Site
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Nancy, France
- Research Site
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Nantes, France
- Research Site
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Nice, France
- Research Site
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Nîmes, France
- Research Site
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Poitiers, France
- Research Site
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Rennes, France
- Research Site
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Rouen, France
- Research Site
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Saint-Etienne, France
- Research Site
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Strasbourg, France
- Research Site
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Toulouse, France
- Research Site
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Tours, France
- Research Site
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Île-de-France - Bicêtre, France
- Research Site
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Île-de-France - Créteil, France
- Research Site
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Île-de-France - Poissy St-Germain, France
- Research Site
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Île-de-France - Pontoise, France
- Research Site
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Île-de-France - Rothschild, France
- Research Site
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Île-de-France - Saint-Antoine, France
- Research Site
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Île-de-France - Saint-Denis, France
- Research Site
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Île-de-France - Salpêtrière, France
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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).
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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.
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Administered as specified in the treatment arm.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Time to ALC Reconstitution After DMF Discontinuation
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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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)
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Up to end of study (121 days)
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Time From DMF Initiation to DMF Discontinuation
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Percentage of Participants with Discontinuation of DMF Treatment
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Percent Change from Baseline in Absolute CD4+ Count
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Percent Change from Baseline in Absolute CD8+ Count
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Percent Change from Baseline in Absolute CD4+/CD8+ Ratio
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation
Time Frame: Up to end of study (121 days)
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This outcome measure will be assessed in subgroup of participants who discontinued DMF in the lymphopenic population.
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Up to end of study (121 days)
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Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression
Time Frame: Up to end of study (121 days)
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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).
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Up to end of study (121 days)
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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)
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Up to end of study (121 days)
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Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population
Time Frame: Up to end of study (121 days)
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Up to end of study (121 days)
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Time to Occurrence of Lymphopenia During DMF Treatment Assessed in Association Between Demographic and Clinical Characteristics
Time Frame: Up to end of study (121 days)
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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.
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Up to end of study (121 days)
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Time to Lymphocyte Reconstitution After DMF Discontinuation Assessed in Association Between Demographic and Clinical Characteristics
Time Frame: Up to end of study (121 days)
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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.
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Up to end of study (121 days)
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Medical Director, Biogen
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immunologic Deficiency Syndromes
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Hematologic Diseases
- Leukopenia
- Leukocyte Disorders
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Lymphopenia
- Physiological Effects of Drugs
- Immunosuppressive Agents
- Immunologic Factors
- Dermatologic Agents
- Dimethyl Fumarate
Other Study ID Numbers
- FR-BGT-11758
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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