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

Biogen

Status: Completed

Conditions: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting

Treatments: Drug: Dimethyl fumarate

Study type: Observational

Funder types: Industry

Identifiers

NCT04756687

FR-BGT-11758

Details and patient eligibility

About

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.

Full description

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

Enrollment: 1,507 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,507 participants in 1 patient group

All Participants

Description:

RRMS participants treated with DMF will be identified in the Observatoire Français de la Sclérose en Plaques (OFSEP) database for OFSEP sites.

Treatment:

Drug: Dimethyl fumarate