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LEMTRADA Pregnancy Registry in Multiple Sclerosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774914
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : August 6, 2019
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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.


Condition or disease Intervention/treatment
Multiple Sclerosis Drug: Alemtuzumab (GZ402673)

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 204 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Months
Official Title: International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Actual Study Start Date : September 1, 2015
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab

Group/Cohort Intervention/treatment
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
Drug: Alemtuzumab (GZ402673)
Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
Other Name: Lemtrada




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Major congenital malformations [ Time Frame: 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)

  2. Minor congenital malformations [ Time Frame: 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)

  3. 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 ]
    Numbers and rates of stillbirth, on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  4. Full-term live birth i.e. infants born maturely (≥37 gestation weeks) [ Time Frame: 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)

  5. 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 ]
    Numbers and rates of pre-term birth on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  6. Elective terminations i.e. any induced or voluntary fetal loss [ Time Frame: 16-20 weeks' gestation ]
    Numbers and rates of elective terminations on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  7. 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 ]
    Numbers and rates of small for gestational age on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  8. Any other adverse pregnancy outcomes [ Time Frame: Baseline to week 40 ]
    Numbers of adverse events

  9. Infant postnatal growth (up to the first year of life) [ Time Frame: 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.

  10. Infant development impairment (up to the first year of life) [ Time Frame: 1 year after delivery ]
    Numbers and rates of infants with development impairment



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774914


Contacts
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Contact: Trial Transparency email recommended (Toll free number for US & Canada) 800-633-1610 ext 1 then # Contact-US@sanofi.com

Locations
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United States, New York
NEW YORK Recruiting
New York, New York, United States, 00000
Austria
Investigational site 040-001 Recruiting
Linz, Austria
Belgium
BELGIUM Recruiting
Belgium, Belgium
Canada
CANADA Recruiting
Canada, Canada
Denmark
DENMARK Recruiting
Denmark, Denmark
Germany
Investigational Site Number 276001 Recruiting
Bochum, Germany
Italy
ITALY Recruiting
Italy, Italy
Spain
SPAIN Recruiting
Spain, Spain
Sweden
SWEDEN Recruiting
Sweden, Sweden
United Kingdom
Investigational Site Number 826-001 Not yet recruiting
Salford, United Kingdom
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi
Additional Information:

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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT03774914    
Other Study ID Numbers: OBS13436
EU PAS - cat 3
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: August 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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://www.clinicalstudydatarequest.com/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Alemtuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents