Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera (Lympho-TEC)

October 20, 2023 updated by: Biogen

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

Completed

Conditions

Intervention / Treatment

Detailed Description

The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.

Study Type

Observational

Enrollment (Actual)

1507

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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
      • 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
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All RRMS participants treated with DMF who fulfil the inclusion criteria are eligible to participate in the study.

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. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
All Participants
RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites.
Drug: Dimethyl fumarate
Administered as specified in the treatment arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to ALC Reconstitution After DMF Discontinuation
Time Frame: Up to end of study (121 days)
Up to end of study (121 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation
Time Frame: Up to end of study (121 days)
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)
Up to end of study (121 days)
Time From DMF Initiation to DMF Discontinuation
Time Frame: Up to end of study (121 days)
Up to end of study (121 days)
Percentage of Participants with Discontinuation of DMF Treatment
Time Frame: Up to end of study (121 days)
Up to end of study (121 days)
Percent Change from Baseline in Absolute CD4+ Count
Time Frame: Up to end of study (121 days)
Up to end of study (121 days)
Percent Change from Baseline in Absolute CD8+ Count
Time Frame: Up to end of study (121 days)
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)
Up to end of study (121 days)
Time From DMF Initiation to Lymphopenia Assessed at Time of DMF Discontinuation
Time Frame: Up to end of study (121 days)
This outcome measure will be assessed in subgroup of participants who discontinued DMF in the lymphopenic population.
Up to end of study (121 days)
Time to DMF Discontinuation to the First Relapses and/or an EDSS Progression
Time Frame: Up to end of study (121 days)
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
Time Frame: Up to end of study (121 days)
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)
Up to end of study (121 days)
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)
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
Time Frame: Up to end of study (121 days)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Investigators

  • Study Director: Medical Director, Biogen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Actual)

June 15, 2021

Study Completion (Actual)

June 15, 2021

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 12, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

October 23, 2023

Last Update Submitted That Met QC Criteria

October 20, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FR-BGT-11758

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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