Status:
COMPLETED
Real World Analysis on Lymphocyte Reconstitution After Lymphopenia in Participants Treated by Tecfidera
Lead Sponsor:
Biogen
Conditions:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18+ years
Brief 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) partici...
Detailed Description
The study will select participants initiating treatment from 01 Jan 2016 to 15 Dec 2020.
Eligibility Criteria
Inclusion
- 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
- Participants will be excluded from the study entry if they express their opposition to collect the data upon the information.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2021
Estimated Enrollment :
1507 Patients enrolled
Trial Details
Trial ID
NCT04756687
Start Date
March 10 2021
End Date
June 15 2021
Last Update
October 23 2023
Active Locations (32)
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1
Research Site
Amiens, France
2
Research Site
Besançon, France
3
Research Site
Bordeaux, France
4
Research Site
Brest, France