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LEMTRADA Pregnancy Registry in Multiple Sclerosis
Sponsor: Genzyme, a Sanofi Company
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.
Official title: International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Key Details
Gender
FEMALE
Age Range
18 Years - 55 Years
Study Type
OBSERVATIONAL
Enrollment
42
Start Date
2015-09-01
Completion Date
2021-11-22
Last Updated
2026-05-29
Healthy Volunteers
Yes
Conditions
Interventions
Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Locations (12)
Site Number : 840999
New York, New York, United States
Investigational Site Number : 036001
Box Hill, Victoria, Australia
Investigational Site Number : 040-001
Linz, Austria
Investigational Site Number : 56
Charleroi, Belgium
Investigational Site Number : 124999
Canada, Canada
Investigational Site Number : 208001
Aarhus C, Denmark
Investigational Site Number : 276001
Bochum, Germany
Investigational Site Number : 380001
Gallarate (VA), Italy
Investigational Site Number : 528999
Netherlands, Netherlands
Investigational Site Number : 724999
Spain, Spain
Investigational Site Number : 752001
Gothenburg, Sweden
Investigational Site Number : 826-001
Salford, United Kingdom