Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT03774914




Registration number
NCT03774914
Ethics application status
Date submitted
11/12/2018
Date registered
13/12/2018
Date last updated
25/04/2022

Titles & IDs
Public title
LEMTRADA Pregnancy Registry in Multiple Sclerosis
Scientific title
International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Secondary ID [1] 0 0
EU PAS - cat 3
Secondary ID [2] 0 0
OBS13436
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Drugs - Alemtuzumab (GZ402673)

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


Treatment: Drugs: Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Spontaneous abortions (=20 weeks gestation)
Timepoint [1] 0 0
32 weeks gestation
Secondary outcome [1] 0 0
Major congenital malformations
Timepoint [1] 0 0
From birth to 1 year after delivery
Secondary outcome [2] 0 0
Minor congenital malformations
Timepoint [2] 0 0
From birth to 1 year after delivery
Secondary outcome [3] 0 0
Stillbirth (any non-deliberate foetal death at >20 weeks gestation)
Timepoint [3] 0 0
26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
Secondary outcome [4] 0 0
Full-term live birth i.e. infants born maturely (=37 gestation weeks)
Timepoint [4] 0 0
Within 6 weeks after the end of the pregnancy
Secondary outcome [5] 0 0
Preterm birth i.e. infants born prematurely i.e., live-born infant i.e., (pre-term <37 weeks)
Timepoint [5] 0 0
26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
Secondary outcome [6] 0 0
Elective terminations i.e. any induced or voluntary fetal loss
Timepoint [6] 0 0
16-20 weeks' gestation
Secondary outcome [7] 0 0
Small for gestational age at birth i.e. birth size (weight, length, or head circumference) =10th percentile for gender and gestational age
Timepoint [7] 0 0
Within 6 weeks after the end of the pregnancy
Secondary outcome [8] 0 0
Any other adverse pregnancy outcomes
Timepoint [8] 0 0
Baseline to week 40
Secondary outcome [9] 0 0
Infant postnatal growth (up to the first year of life)
Timepoint [9] 0 0
1 year after delivery
Secondary outcome [10] 0 0
Infant development impairment (up to the first year of life)
Timepoint [10] 0 0
1 year after delivery

Eligibility
Key inclusion 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/11/2021
Sample size
Target
Accrual to date
Final
42
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigational Site Number :036001 - Box Hill
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
Austria
State/province [2] 0 0
Linz
Country [3] 0 0
Belgium
State/province [3] 0 0
Charleroi
Country [4] 0 0
Canada
State/province [4] 0 0
Canada
Country [5] 0 0
Denmark
State/province [5] 0 0
Aarhus C
Country [6] 0 0
Germany
State/province [6] 0 0
Bochum
Country [7] 0 0
Italy
State/province [7] 0 0
Gallarate (VA)
Country [8] 0 0
Netherlands
State/province [8] 0 0
Netherlands
Country [9] 0 0
Spain
State/province [9] 0 0
Spain
Country [10] 0 0
Sweden
State/province [10] 0 0
Göteborg
Country [11] 0 0
Switzerland
State/province [11] 0 0
Zürich
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Salford

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Genzyme, a Sanofi Company
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03774914
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Sciences & Operations
Address 0 0
Sanofi
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03774914