International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
Research type
Research Study
Full title
International LEMTRADA Pregnancy Exposure Cohort in Multiple Sclerosis
IRAS ID
177317
Contact name
David Rog
Contact email
Sponsor organisation
Genzyme Corporation
Duration of Study in the UK
5 years, 6 months, 1 days
Research summary
This post authorisation safety study (PASS) is an international, observational (registry) study of pregnancy outcomes in women with multiple sclerosis (MS) who had been taking to LEMTRADA (alemtuzumab) during pregnancy. No experimental intervention will be administered in this registry.
LEMTRADA is an intravenous infusion medicine consisted of an antibody for the treatment of patients with active relapsing-remitting MS. LEMTRADA binds to a type of antigen called CD52. The way LEMTRADA works on MS is unknown. There are no adequate and well-controlled studies of LEMTRADA in pregnant women. It is not known whether LEMTRADA can affect reproductive capacity or cause foetal harm when taken by a pregnant woman.
This study is to evaluate pregnancy outcomes in women who had been taking LEMTRADA during pregnancy and to determine if the risk of any adverse pregnancy outcomes in these women exceeds the risks in women with MS who have not been taking LEMTRADA during pregnancy.
The pregnancy outcomes to be assessed include: spontaneous abortion, stillbirth, foetal major malformations, preterm birth, and small for gestational age at birth. For all live births, the infant’s Health Care Provider (HCP) will be contacted at 1 year post-delivery to obtain follow-up on the infant’s health status.
Currently pregnant women with MS who were or became pregnant within the period of time between the first infusion of a course of treatment with LEMTRADA to 4 monthsafter their last infusion will be eligible to participate in this registry.Participants will be in this registry for approximately 21 months: which includes up to 7 to 9 months until the end of pregnancy (depending on the time of the enrolment) and an additional 1-year follow-up of the baby if applicable. Participants may receive treatment and evaluations for their MS and their pregnancies as determined by their doctors in accordance with local standard of care.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0188
Date of REC Opinion
7 May 2015
REC opinion
Further Information Favourable Opinion