Study type

Study topic

Disease /health condition
Human medicinal product

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Safety study (incl. comparative)

Data collection methods

Combined primary data collection and secondary use of data
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

International, observational registry
Study drug and medical condition

Study drug International non-proprietary name (INN) or common name

ALEMTUZUMAB

Medical condition to be studied

Multiple sclerosis
Population studied

Short description of the study population

Pregnant women with multiple sclerosis (MS) who had any pregnancy exposure to LEMTRADA between 10 August 2015 and 22 November 2021 from North America, Europe, and the rest of the world.
Inclusion criteria:
- Women with MS who were or became pregnant within the period of time between the first
infusion of a course of treatment with LEMTRADA to 4 months after their last infusion for
that course.
- Able and willing to provide informed consent for study participation and the requirement
of the study. Informed consent will be obtained at the time of enrollment in accordance
with local regulatory requirements.

Exclusion criteria:
- Previous enrollment in this study for a previous pregnancy.

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)

Special population of interest

Other
Pregnant women

Special population of interest, other

Patients with multiple sclerosis

Estimated number of subjects

42
Study design details

Main study objective

To assess adverse pregnancy outcomes in women exposed to LEMTRADA during pregnancy. Pregnancy outcomes assessed will include: spontaneous abortion, stillbirth, fetal major malformations, preterm birth, and small for gestational age at birth.

Outcomes

To determine if the risk of any adverse pregnancy and fetal outcomes in women exposed to LEMTRADA exceeds the risks in women with MS who have not been exposed to LEMTRADA during pregnancy. To further characterize prenatally-exposed live births, outcomes in the neonatal and pediatric periods up to one year of age, which will be assessed pending available data.

Data analysis plan

Rates and 95% confidence intervals (CI) of pregnancy outcomes for women exposed to LEMTRADA during pregnancy will be calculated. These rates will be compared with corresponding rates in a primary external comparison cohort of women with MS who have not been exposed to LEMTRADA during pregnancy.