LEMTRADA Pregnancy Registry in Multiple Sclerosis

International LEMTRADA Pregnancy Exposure Cohort 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.

Study Overview

• Status: Terminated
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Alemtuzumab (GZ402673)

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Investigational Site Number :036001
• Austria
  • Linz, Austria
    • Investigational Site Number :040-001
• Belgium
  • Charleroi, Belgium, 6000
    • Investigational Site Number :56
• Canada
  • Canada, Canada
    • Investigational Site Number :124999
• Denmark
  • Aarhus C, Denmark, 8000
    • Investigational Site Number :208001
• Germany
  • Bochum, Germany, 44791
    • Investigational Site Number :276001
• Italy
  • Gallarate (VA), Italy, 21013
    • Investigational Site Number :380001
• Netherlands
  • Netherlands, Netherlands
    • Investigational Site Number :528999
• Spain
  • Spain, Spain
    • Investigational Site Number :724999
• Sweden
  • Göteborg, Sweden, 41345
    • Investigational Site Number :752001
• Switzerland
  • Zürich, Switzerland, 8091
    • Investigational Site Number :756001
• United Kingdom
  • Salford, United Kingdom, M6 8HD
    • Investigational Site Number :826-001
• United States
  • New York
    • New York, New York, United States, 00000
      • Investigational Site Number :840999

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lemtrada; Pregnant women exposed to LEMTRADA which is administered by IV infusion for 5 consecutive days, then for 3 consecutive days, 12 months after the first/previous treatment course	Drug: Alemtuzumab (GZ402673); Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion; Other Names: Lemtrada

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spontaneous abortions (≤20 weeks gestation)	Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	32 weeks gestation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major congenital malformations	Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	From birth to 1 year after delivery
Minor congenital malformations	Numbers and rates of minor congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	From birth to 1 year after delivery
Stillbirth (any non-deliberate foetal death at >20 weeks gestation)	Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
Full-term live birth i.e. infants born maturely (≥37 gestation weeks)	Numbers and rates of full-term live birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	Within 6 weeks after the end of the pregnancy
Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)	Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
Elective terminations i.e. any induced or voluntary fetal loss	Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	16-20 weeks' gestation
Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age	Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)	Within 6 weeks after the end of the pregnancy
Any other adverse pregnancy outcomes	Numbers of adverse events	Baseline to week 40
Infant postnatal growth (up to the first year of life)	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.	1 year after delivery
Infant development impairment (up to the first year of life)	Numbers and rates of infants with development impairment	1 year after delivery

Collaborators and Investigators

• Sponsor: Genzyme, a Sanofi Company

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2015
• Primary Completion (ACTUAL): November 22, 2021
• Study Completion (ACTUAL): November 22, 2021

Study Registration Dates

• First Submitted: December 11, 2018
• First Submitted That Met QC Criteria: December 11, 2018
• First Posted (ACTUAL): December 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 21, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Antineoplastic Agents; Antineoplastic Agents, Immunological; Alemtuzumab
• Other Study ID Numbers: OBS13436; EU PAS - cat 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No