LEMTRADA Pregnancy Registry in Multiple Sclerosis

NCT03774914 | Terminated

• 2 other identifiers: OBS13436EU PAS - cat 3
• Study Type: observational
• Target: 42
• Locations: 12 countries
• Sites: 12

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Spontaneous abortions (≤20 weeks gestation)

  Number and rate of spontaneous abortions on pregnant women prospectively enrolled (pregnancy outcome unknown at time of enrollment)

  32 weeks gestation

Secondary Outcomes (10)

• Major congenital malformations

  From birth to 1 year after delivery

• Minor congenital malformations

  From birth to 1 year after delivery

• Stillbirth (any non-deliberate foetal death at >20 weeks gestation)

  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)

  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)

  26-32 weeks' gestation to within 6 weeks after the end of the pregnancy

Study Arms (1)

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)

Interventions

Alemtuzumab (GZ402673) DRUG

Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion

Also known as: Lemtrada

Lemtrada

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Genzyme, a Sanofi Company: lead

Study Sites (13)

Investigational Site Number :840999

New York, New York, 00000, United States

Location

Investigational Site Number :036001

Box Hill, Victoria, 3128, Australia

Location

Investigational Site Number :040-001

Linz, Austria

Location

Investigational Site Number :56

Charleroi, 6000, Belgium

Location

Investigational Site Number :124999

Canada, Canada

Location

Investigational Site Number :208001

Aarhus C, 8000, Denmark

Location

Investigational Site Number :276001

Bochum, 44791, Germany

Location

Investigational Site Number :380001

Gallarate (VA), 21013, Italy

Location

Investigational Site Number :528999

Netherlands, Netherlands

Location

Investigational Site Number :724999

Spain, Spain

Location

Investigational Site Number :752001

Gothenburg, 41345, Sweden

Location

Investigational Site Number :756001

Zurich, 8091, Switzerland

Location

Investigational Site Number :826-001

Salford, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2018
• First Posted: December 13, 2018
• Study Start: September 1, 2015
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: April 25, 2022

Record last verified: 2022-04-21

Data Sharing

• IPD Sharing: Will share

Locations

AU (1); GB (1); NL (1); US (1); ES (1); DE (1); CA (1); SE (1); CH (1); BE (1); IT (1); DK (1)