LEMTRADA Pregnancy Registry in Multiple Sclerosis

Genzyme

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Drug: Alemtuzumab (GZ402673)

Study type: Observational

Funder types: Industry

Identifiers

NCT03774914

EU PAS - cat 3

OBS13436

Details and patient eligibility

About

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.

Full description

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

Enrollment: 42 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

42 participants in 1 patient group

Lemtrada

Description:

Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course

Treatment:

Drug: Alemtuzumab (GZ402673)