A STUDY TO EVALUATE THE POTENTIAL EXPOSURE OF INFANTS TO OCRELIZUMAB DURING PREGNANCY - THE MINORE STUDY
Research type
Research Study
Full title
MN42988 - A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS POTENTIALLY EXPOSED TO OCRELIZUMAB DURING PREGNANCY – THE MINORE STUDY
IRAS ID
303444
Contact name
Head of EU Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-000062-14
Duration of Study in the UK
1 years, 11 months, 2 days
Research summary
The objective of this study is to understand the potential effect of a drug called ocrelizumab on babies born to women living with Multiple Sclerosis (MS) who received Ocrelizumab some time up to six months before they became pregnant, or in the first three months (the first trimester) of their pregnancy.
Ocrelizumab is a type of drug called a monoclonal antibody that acts like the body's immune system by attaching to viruses, bacteria and certain body cells in order to fight infections and other illnesses. Ocrelizumab attaches to a type of white blood cell (called a “B cell”) that is thought to play a role in MS.
About 44 pregnant women living with MS across several countries will take part in this study. Approximately half of these women will have had their last dose of ocrelizumab within 3 months of getting pregnant, or in the first 3 months of their pregnancy (in these women, there is a potential chance that ocrelizumab may have crossed the placenta and reached their unborn babies).
REC name
London - Hampstead Research Ethics Committee
REC reference
21/LO/0624
Date of REC Opinion
15 Oct 2021
REC opinion
Further Information Favourable Opinion