Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera

Multiple Sclerosis Clinical Trial

— Lympho-TEC  

Official title:

A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04756687
• Other study ID #: FR-BGT-11758
• Status: Completed
• Start date: March 10, 2021
• Est. completion date: June 15, 2021

Study information

• Verified date: October 2023
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1507
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphopenia
• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

Drug:
• Dimethyl fumarate
Administered as specified in the treatment arm.

Locations

Country	Name	City	State
France	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	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

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to ALC Reconstitution After DMF Discontinuation		Up to end of study (121 days)
Secondary	Time From DMF Initiation to Lymphopenia Initiation Assessed in Participants With and Without DMF Discontinuation		Up to end of study (121 days)
Secondary	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.	Up to end of study (121 days)
Secondary	Percent Change in ALC Over Time From DMF Initiation to DMF Discontinuation or End of Study		Up to end of study (121 days)
Secondary	Time From DMF Initiation to DMF Discontinuation		Up to end of study (121 days)
Secondary	Percentage of Participants with Discontinuation of DMF Treatment		Up to end of study (121 days)
Secondary	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)
Secondary	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)
Secondary	Percentage of Participants With Serious and Opportunistic Infections in Overall and in Lymphopenic Population		Up to end of study (121 days)
Secondary	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)
Secondary	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)
Secondary	Percent Change from Baseline in Absolute CD4+ Count		Up to end of study (121 days)
Secondary	Percent Change from Baseline in Absolute CD8+ Count		Up to end of study (121 days)
Secondary	Percent Change from Baseline in Absolute CD4+/CD8+ Ratio		Up to end of study (121 days)