Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
42 participants
OBSERVATIONAL
2015-09-01
2021-11-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Lemtrada
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
Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Interventions
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Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
18 Years
55 Years
FEMALE
No
Sponsors
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Genzyme, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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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
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 :756001
Zurich, , Switzerland
Investigational Site Number :826-001
Salford, , United Kingdom
Countries
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Other Identifiers
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EU PAS - cat 3
Identifier Type: -
Identifier Source: secondary_id
OBS13436
Identifier Type: -
Identifier Source: org_study_id
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