LEMTRADA Pregnancy Registry in Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 2 May 2022
• Main ID: NCT03774914
• Date of registration: 11/12/2018
• Prospective Registration: No
• Primary sponsor: Genzyme, a Sanofi Company
• Public title: LEMTRADA Pregnancy Registry in Multiple Sclerosis
• Scientific title: International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
• Date of first enrolment: September 1, 2015
• Target sample size: 42
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03774914
• Study type: Observational [Patient Registry]

Countries of recruitment

Australia, Austria, Belgium, Canada, Denmark, Germany, Italy, Netherlands, Spain, Sweden, Switzerland, United Kingdom, United States

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Drug: Alemtuzumab (GZ402673)

Primary Outcome(s)

Spontaneous abortions (=20 weeks gestation) [Time Frame: 32 weeks gestation]

Secondary Outcome(s)

Major congenital malformations [Time Frame: From birth to 1 year after delivery]

Infant postnatal growth (up to the first year of life) [Time Frame: 1 year after delivery]

Elective terminations i.e. any induced or voluntary fetal loss [Time Frame: 16-20 weeks' gestation]

Minor congenital malformations [Time Frame: From birth to 1 year after delivery]

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]

Full-term live birth i.e. infants born maturely (=37 gestation weeks) [Time Frame: Within 6 weeks after the end of the pregnancy]

Any other adverse pregnancy outcomes [Time Frame: Baseline to week 40]

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]

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]

Infant development impairment (up to the first year of life) [Time Frame: 1 year after delivery]

Secondary ID(s)

EU PAS - cat 3

OBS13436

Source(s) of Monetary Support

Please refer to primary and secondary sponsors