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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/47892
• EU PAS number:
  EUPAS39505
• Study ID:
  47892
• Official title and acronym:
  A Retrospective Analysis in Real World on Lymphocyte Reconstitution After Lymphopenia in Patients Treated by Tecfidera and Description of Management Strategies in France (Lympho-TEC)
• DARWIN EU® study:
  No
• Study countries:
  France
• Study description:
  The primary objective of the study is to describe absolute lymphocyte count (ALC) reconstitution after Dimethyl fumarate (DMF) discontinuation because of lymphopenia, in Relapsing-Remitting Multiple Sclerosis (RRMS) subjects.
• Study status:
  Finalised

Research institutions and networks

Institutions

Biogen

Study timelines

Date when funding contract was signed

Planned: 17/12/2020

Actual: 17/12/2020

Study start date

Planned: 15/02/2021

Actual: 10/03/2021

Date of final study report

Planned: 31/01/2022

Actual: 07/10/2023

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Biogen

Study protocol

Initial protocol

LymphoTEC_protocol_Redacted.pdf

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

FR-BGT-11758

Link to Clinicaltrials.gov