LEMTRADA Pregnancy Registry in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

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

Official Title
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International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Alemtuzumab (GZ402673)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lemtrada<br>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 | Drug: Alemtuzumab (GZ402673)<br>* Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion<br>* Other names: Lemtrada;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spontaneous abortions (≤20 weeks gestation) | Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) | 32 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major congenital malformations | Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) | 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) | 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) | 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) | 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) | 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy | 
| Elective terminations i.e. any induced or voluntary fetal loss | Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) | 16-20 weeks' gestation | 
| Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age | Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) | Within 6 weeks after the end of the pregnancy | 
| Any other adverse pregnancy outcomes | Numbers of adverse events | Baseline to week 40 | 
| Infant postnatal growth (up to the first year of life) | Numbers and rates of infants with postnatal size (weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants. | 1 year after delivery | 
| Infant development impairment (up to the first year of life) | Numbers and rates of infants with development impairment | 1 year after delivery |