LEMTRADA Pregnancy Registry in Multiple Sclerosis

Terminated

• Conditions: Multiple Sclerosis
• Interventions: Drug: Alemtuzumab (GZ402673)

• Registration Number: NCT03774914
• Lead Sponsor: Genzyme, a Sanofi Company

Brief Summary

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

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

Study Timeline

• Study Start: 2015-09-01
• Study First Submitted: 2018-12-11
• Study First Submitted QC: 2018-12-11
• Study First Posted: 2018-12-13
• Primary Completion: 2021-11-22
• Study Completion: 2021-11-22
• Status Verified: 2022-04-21
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 42

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lemtrada	Alemtuzumab (GZ402673)	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

Primary Outcome Measures

Name	Time	Method
Spontaneous abortions (≤20 weeks gestation)	32 weeks gestation	Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Secondary Outcome Measures

Name	Time	Method
Elective terminations i.e. any induced or voluntary fetal loss	16-20 weeks' gestation	Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Minor congenital malformations	From birth to 1 year after delivery	Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Any other adverse pregnancy outcomes	Baseline to week 40	Numbers of adverse events
Stillbirth (any non-deliberate foetal death at >20 weeks gestation)	26-32 weeks' gestation to within 6 weeks after the end of the pregnancy	Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Full-term live birth i.e. infants born maturely (≥37 gestation weeks)	Within 6 weeks after the end of the pregnancy	Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)	26-32 weeks' gestation to within 6 weeks after the end of the pregnancy	Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Infant postnatal growth (up to the first year of life)	1 year after delivery	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.
Major congenital malformations	From birth to 1 year after delivery	Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Infant development impairment (up to the first year of life)	1 year after delivery	Numbers and rates of infants with development impairment
Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age	Within 6 weeks after the end of the pregnancy	Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Trial Locations

Locations (13)

Investigational Site Number :56; 🇧🇪 Charleroi, Belgium

Investigational Site Number :040-001; 🇦🇹 Linz, Austria

Investigational Site Number :124999; 🇨🇦 Canada, Canada

Investigational Site Number :840999; 🇺🇸 New York, New York, United States

Investigational Site Number :036001; 🇦🇺 Box Hill, Victoria, Australia

Investigational Site Number :208001; 🇩🇰 Aarhus C, Denmark

Investigational Site Number :380001; 🇮🇹 Gallarate (VA), Italy

Investigational Site Number :276001; 🇩🇪 Bochum, Germany

Investigational Site Number :528999; 🇳🇱 Netherlands, Netherlands

Investigational Site Number :756001; 🇨🇭 Zürich, Switzerland

Investigational Site Number :752001; 🇸🇪 Göteborg, Sweden

Investigational Site Number :826-001; 🇬🇧 Salford, United Kingdom

Investigational Site Number :724999; 🇪🇸 Spain, Spain