Multiple SclerosisNCT03774914
LEMTRADA Pregnancy Registry in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by Genzyme, a Sanofi Company at 12 sites in 12 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Alemtuzumab (GZ402673)
- Type of treatment
- Injection or infusion
- How many people
- 42 participants
- Where
- 12 sitesin 12 countries
- Study dates
- 1 Sep 2015to 22 Nov 2021
- How long will I take part?
- 20 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
12 sites in 12 countries.
12 sites in 12 countries
Australia1 site
Investigational Site Number : 036001
Box Hill, Victoria, 3128
United Kingdom1 site
Investigational Site Number : 826-001
Salford, M6 8HD
About this study
Official title: 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.
Read the detailed description
From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)
- Conditions
- Multiple Sclerosis
- Being tested
- Alemtuzumab (GZ402673)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alemtuzumab (GZ402673)Drug
Also called Lemtrada
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Alemtuzumab (GZ402673) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous abortions (≤20 weeks gestation)
Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Measured: 32 weeks gestation
Secondary outcomes (10)
Major congenital malformations
Numbers and rates of major congenital malformations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: Within 6 weeks after the end of the pregnancy
Any other adverse pregnancy outcomes
Numbers of adverse events
Measured: 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.
Measured: 1 year after delivery
Infant development impairment (up to the first year of life)
Numbers and rates of infants with development impairment
Measured: 1 year after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2018
- Study start1 Sep 2015
- Primary completion22 Nov 2021
- Study completion22 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 20 Months
Sponsor and investigators
- Lead sponsor
- Genzyme, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03774914
- Sponsor's protocol ID
- OBS13436
- Other IDs
- EU PAS - cat 3, U1111-1225-1263, EUPAS7574
- Status last verified
- May 2026
- First submitted
- 11 Dec 2018
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03774914
- Acronym / sponsor ID
- OBS13436
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Genzyme, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 22 Nov 2021 (actual)
- Study completion
- 22 Nov 2021 (actual)
- First posted
- 13 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lemtrada | – | Drug: Alemtuzumab (GZ402673)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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alemtuzumab (GZ402673)Also: LemtradaPharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion | Drug | Lemtrada |
Primary outcome
Spontaneous abortions (≤20 weeks gestation)
Time frame: 32 weeks gestation
Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)
10 secondary outcomes
Major congenital malformations
Time frame: From birth to 1 year after delivery
Minor congenital malformations
Time frame: From birth to 1 year after delivery
Stillbirth (any non-deliberate foetal death at >20 weeks gestation)
Time frame: 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)
Time frame: 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)
Time frame: 26-32 weeks' gestation to within 6 weeks after the end of the pregnancy
Elective terminations i.e. any induced or voluntary fetal loss
Time frame: 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
Time frame: Within 6 weeks after the end of the pregnancy
Any other adverse pregnancy outcomes
Time frame: Baseline to week 40
Infant postnatal growth (up to the first year of life)
Time frame: 1 year after delivery
Infant development impairment (up to the first year of life)
Time frame: 1 year after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis (OBS13436)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
12 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Genzyme, a Sanofi Company at 12 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Australia, Austria, Belgium, Canada and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous abortions (≤20 weeks gestation) (time frame: 32 weeks gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.