Multiple Sclerosis
Conditions
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)
Interventions
DRUGAlemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Sponsors
Genzyme, a Sanofi Company
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous abortions (≤20 weeks gestation) | 32 weeks gestation | Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Major congenital malformations | 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) |
| Minor congenital malformations | 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) |
| Stillbirth (any non-deliberate foetal death at >20 weeks gestation) | 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) |
| Full-term live birth i.e. infants born maturely (≥37 gestation weeks) | 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) |
| Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks) | 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) |
| Elective terminations i.e. any induced or voluntary fetal loss | 16-20 weeks' gestation | Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment) |
| Small for gestational age at birth i.e. birth size (weight, length, or head circumference) ≤10th percentile for gender and gestational age | 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) |
| Any other adverse pregnancy outcomes | Baseline to week 40 | Numbers of adverse events |
| Infant postnatal growth (up to the first year of life) | 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. |
| Infant development impairment (up to the first year of life) | 1 year after delivery | Numbers and rates of infants with development impairment |
Countries
Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Netherlands, Spain, Sweden, United Kingdom, United States
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Outcome results
None listed