Clinical trial NCT03774914: LEMTRADA Pregnancy Registry in Multiple Sclerosis
Official title: International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2018-12-13
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Spontaneous abortions (≤20 weeks gestation)
timeFrame: 32 weeks gestation
Secondary outcomes:
measure: Major congenital malformations
timeFrame: From birth to 1 year after delivery
measure: Minor congenital malformations
timeFrame: From birth to 1 year after delivery
measure: Stillbirth (any non-deliberate foetal death at >20 weeks gestation)
timeFrame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
measure: Full-term live birth i.e. infants born maturely (≥37 gestation weeks)
timeFrame: Within 6 weeks after the end of the pregnancy
measure: Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)
timeFrame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
measure: Elective terminations i.e. any induced or voluntary fetal loss
timeFrame: 16-20 weeks' gestation
measure: Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age
timeFrame: Within 6 weeks after the end of the pregnancy
measure: Any other adverse pregnancy outcomes
timeFrame: Baseline to week 40
measure: Infant postnatal growth (up to the first year of life)
timeFrame: 1 year after delivery
measure: Infant development impairment (up to the first year of life)
timeFrame: 1 year after delivery
Other outcomes:
Locations:
city: New York
country: United States
facility: Investigational Site Number :840999
state: New York
city: Box Hill
country: Australia
facility: Investigational Site Number :036001
state: Victoria
city: Linz
country: Austria
facility: Investigational Site Number :040-001
city: Charleroi
country: Belgium
facility: Investigational Site Number :56
city: Canada
country: Canada
facility: Investigational Site Number :124999
city: Aarhus C
country: Denmark
facility: Investigational Site Number :208001
city: Bochum
country: Germany
facility: Investigational Site Number :276001
city: Gallarate (VA)
country: Italy
facility: Investigational Site Number :380001
city: Netherlands
country: Netherlands
facility: Investigational Site Number :528999
city: Spain
country: Spain
facility: Investigational Site Number :724999
city: Göteborg
country: Sweden
facility: Investigational Site Number :752001
city: Zürich
country: Switzerland
facility: Investigational Site Number :756001
city: Salford
country: United Kingdom
facility: Investigational Site Number :826-001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: