MS drug LEMTRADA under pregnancy microscope: what are the risks?

NCT ID NCT03774914

Completed Knowledge-focused Sponsor: Genzyme, a Sanofi Company Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This completed study tracked 42 women with multiple sclerosis who became pregnant around the time they received LEMTRADA infusions. Researchers aimed to measure rates of miscarriage and birth defects to better understand the drug's safety during pregnancy. The study did not test a new treatment but gathered real-world data to guide future medical advice.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Alemtuzumab (Lemtrada)
What this could lead to: If successful, this study could provide clearer safety data on LEMTRADA use during pregnancy, helping women with MS make informed family-planning decisions.
What could go wrong: This is an observational registry with only 42 participants, so results may not apply broadly. It does not test a new treatment, only monitors existing drug exposure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

MULTIPLE SCLEROSIS

Contacts and locations

Locations

Investigational Site Number : 036001

Box Hill, Victoria, 3128, Australia
Investigational Site Number : 040-001

Linz, Austria
Investigational Site Number : 124999

Canada, Canada
Investigational Site Number : 208001

Aarhus C, 8000, Denmark
Investigational Site Number : 276001

Bochum, 44791, Germany
Investigational Site Number : 380001

Gallarate (VA), 21013, Italy
Investigational Site Number : 528999

Netherlands, Netherlands
Investigational Site Number : 56

Charleroi, 6000, Belgium
Investigational Site Number : 724999

Spain, Spain
Investigational Site Number : 752001

Gothenburg, 41345, Sweden
Investigational Site Number : 826-001

Salford, M6 8HD, United Kingdom
Site Number : 840999

New York, New York, United States

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