LEMTRADA Pregnancy Registry in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03774914
• Other study ID #: OBS13436
• Secondary ID: EU PAS - cat 3
• Status: Terminated
• Start date: September 1, 2015
• Est. completion date: November 22, 2021

Study information

• Verified date: April 21, 2022
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: November 22, 2021
• Est. primary completion date: November 22, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion

Locations

Country	Name	City	State
Australia	Investigational Site Number :036001	Box Hill	Victoria
Austria	Investigational Site Number :040-001	Linz
Belgium	Investigational Site Number :56	Charleroi
Canada	Investigational Site Number :124999	Canada
Denmark	Investigational Site Number :208001	Aarhus C
Germany	Investigational Site Number :276001	Bochum
Italy	Investigational Site Number :380001	Gallarate (VA)
Netherlands	Investigational Site Number :528999	Netherlands
Spain	Investigational Site Number :724999	Spain
Sweden	Investigational Site Number :752001	Göteborg
Switzerland	Investigational Site Number :756001	Zürich
United Kingdom	Investigational Site Number :826-001	Salford
United States	Investigational Site Number :840999	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Denmark,  Germany,  Italy,  Netherlands,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Any other adverse pregnancy outcomes	Numbers of adverse events	Baseline to week 40
Secondary	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
Secondary	Infant development impairment (up to the first year of life)	Numbers and rates of infants with development impairment	1 year after delivery