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 type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Case-series

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  DIMETHYL FUMARATE
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  1507

Study design details

• Main study objective:
  The primary objective(s) 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.
• Outcomes:
  Time to Absolute Lymphocyte Count (ALC) Reconstitution After Dimethyl Fumarate (DMF) Discontinuation. Time From DMF Initiation to Lymphopenia Initiation and DMF discontinuation, Longitudinal evolution of ALC over time, Percentage of patients showing relapses and/or an EDSS progression, Serious Adverse events, Opportunistic or serious infections, Association between baseline demographic and clinical characteristics on the occurrence of lymphopenia and lymphocyte reconstitution.
• Data analysis plan:
  Normality of distribution of continuous parameters will be verified by at least 2 statistical tests and visually checked. All statistical tests will be 2-sided and with a statistically significant threshold set at 5%. Missing data will be handled for the main criterion only. At least 2 different methods will be used and detailed in the SAP.

Documents

Study report

LymphoTEC_CSR Synopsis_Redacted.pdf