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LEMTRADA Pregnancy Registry in Multiple Sclerosis

CompletedN/A

Sponsor: Genzyme, a Sanofi Company

Conditions: Multiple Sclerosis

Interventions: Alemtuzumab (GZ402673)

Countries: United States, Australia, Austria, Belgium, Canada, Denmark, Germany, Italy

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.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 55 Years

Healthy volunteers: Yes

Study type: OBSERVATIONAL

Eligibility 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.

Locations (12)

New York, New York, United States
Box Hill, Victoria, Australia
Linz, Austria
Charleroi, Belgium
Canada, Canada
Aarhus C, Denmark
Bochum, Germany
Gallarate (VA), Italy
Netherlands, Netherlands
Spain, Spain
Gothenburg, Sweden
Salford, United Kingdom