Status:
TERMINATED
LEMTRADA Pregnancy Registry in Multiple Sclerosis
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Multiple Sclerosis
Eligibility:
FEMALE
18-55 years
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...
Detailed Description
From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 22 2021
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03774914
Start Date
September 1 2015
End Date
November 22 2021
Last Update
April 25 2022
Active Locations (13)
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1
Investigational Site Number :840999
New York, New York, United States, 00000
2
Investigational Site Number :036001
Box Hill, Victoria, Australia, 3128
3
Investigational Site Number :040-001
Linz, Austria
4
Investigational Site Number :56
Charleroi, Belgium, 6000