LEMTRADA Pregnancy Registry in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis

In brief

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.

Key facts

Study ID

NCT03774914

Run by

Genzyme, a Sanofi Company

People needed

42

Starts

2015-09-01

Expected to finish

2021-11-22

Last updated by the study team

2026-05-29

Who can join

Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.