Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Name of medicine

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

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 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 AESI, Descriptive statistics on the incidence of AEs, SAEs, deaths.

Data analysis plan

The incidence proportion of each 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 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.