LEMTRADA Pregnancy Registry in Multiple Sclerosis

International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis

Primary Objective:

The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis.

Secondary Objective:

The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.

From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)

Inclusion criteria :

• Women with Multiple Sclerosis 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.
• Women 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.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.