A prospective, multicenter, observational, post-authorization safety study (PASS) to evaluate the long term safety profile of LEMTRADA® (alemtuzumab) treatment in patients with relapsing forms of multiple sclerosis (RMS) (GZ402673-OBS13434)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  LEMTRADA
• Study drug International non-proprietary name (INN) or common name:
  ALEMTUZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG06) alemtuzumab

  alemtuzumab
• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• Short description of the study population:
  Patients with relapsing forms of multiple sclerosis (RMS)
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  The overall goal of the study is to better characterize the long-term safety profile of LEMTRADA treatment in relapsing multiple sclerosis (RMS) patients and to determine the incidence of adverse event of special interest (AESI).
• Outcomes:
  To further evaluate the necessary duration of monitoring following treatment with LEMTRADA for MS and to further inform appropriate monitoring conditions. Incidence of AESIs, associations between risk factors and incidence of adverse event of special interest (AESI), Descriptive statistics on the incidence of adverse events (AEs), serious adverse events (SAEs), deaths.
• Data analysis plan:
  The incidence proportion of each adverse event of special interest (AESI) (number of patients with at least one event divided by total number of patients) will be reported together with an exact binomial 95% two-sided confidence interval (CI). Supportive analyses will include, but will not be limited to, the rates over time (number of events and the number of patients with at least one event divided by the total number of person-years at risk of follow-up for the period) of each AESI with an exact Poisson 95% two-sided CI. For temporally associated AESIs, only incidence proportions, but not rates, will be considered.