Trials / Terminated
TerminatedNCT03774914
LEMTRADA Pregnancy Registry in Multiple Sclerosis
International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 42 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Female
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Alemtuzumab (GZ402673) | Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2021-11-22
- Completion
- 2021-11-22
- First posted
- 2018-12-13
- Last updated
- 2022-04-25
Locations
13 sites across 13 countries: United States, Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03774914. Inclusion in this directory is not an endorsement.