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Completed

NCT Number: NCT03774914

LEMTRADA Pregnancy Registry in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

Female

Study type

Observational

Primary location

Investigational Site Number : 036001, Box Hill, Victoria, Australia

Loading trial locations.

About this study

From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Alemtuzumab (GZ402673)

Drug

Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion

Other names: Lemtrada

Primary outcomes

  1. Spontaneous abortions (≤20 weeks gestation)

    Time frame: 32 weeks gestation

    Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

Secondary outcomes

  1. Major congenital malformations

    Time frame: From birth to 1 year after delivery

    Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  2. Minor congenital malformations

    Time frame: From birth to 1 year after delivery

    Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  3. Stillbirth (any non-deliberate foetal death at >20 weeks gestation)

    Time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

    Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  4. Full-term live birth i.e. infants born maturely (≥37 gestation weeks)

    Time frame: Within 6 weeks after the end of the pregnancy

    Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  5. Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)

    Time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

    Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  6. Elective terminations i.e. any induced or voluntary fetal loss

    Time frame: 16-20 weeks' gestation

    Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  7. Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age

    Time frame: Within 6 weeks after the end of the pregnancy

    Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  8. Any other adverse pregnancy outcomes

    Time frame: Baseline to week 40

    Numbers of adverse events

  9. Infant postnatal growth (up to the first year of life)

    Time frame: 1 year after delivery

    Numbers and rates of infants with postnatal size (weight, length or head circumference) less than or equal to the 10th percentile for sex and age using National Center for Health Statistics (NCHS) pediatric growth curves, and adjusted postnatal age for premature infants.

  10. Infant development impairment (up to the first year of life)

    Time frame: 1 year after delivery

    Numbers and rates of infants with development impairment

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study title

International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Dec 13, 2018
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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