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

NCT ID NCT03774914

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Participants

42 people

The number who actually took part.

Started

Sep 2015

Finished

Nov 2021

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 55 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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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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