LEMTRADA Pregnancy Registry in Multiple Sclerosis

Genzyme, a Sanofi Company42 enrolled

Overview

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)

Study Type

OBSERVATIONAL

Enrollment

Conditions

Multiple Sclerosis

Interventions

Alemtuzumab (GZ402673)DRUG

Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (13)

Investigational Site Number :840999

New York, New York, United States

Investigational Site Number :036001

Box Hill, Victoria, Australia

Investigational Site Number :040-001

Linz, Austria

Outcomes

Primary Outcomes

Spontaneous abortions (≤20 weeks gestation)

Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: 32 weeks gestation

Secondary Outcomes

Major congenital malformations

Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: From birth to 1 year after delivery

Minor congenital malformations

Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: From birth to 1 year after delivery

Stillbirth (any non-deliberate foetal death at >20 weeks gestation)

Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

Full-term live birth i.e. infants born maturely (≥37 gestation weeks)

Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: Within 6 weeks after the end of the pregnancy

Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)

Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

Data from ClinicalTrials.gov

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