MN42989 - Ocrelizumab and breastmilk transfer
Research type
Research Study
Full title
MN42989 - A PHASE IV MULTICENTER, OPEN-LABEL STUDY EVALUATING B CELL LEVELS IN INFANTS OF LACTATING WOMEN WITH CIS OR MS RECEIVING OCRELIZUMAB – THE SOPRANINO STUDY
IRAS ID
303588
Contact name
Head of EU Product Development Regulatory
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-000063-79
Duration of Study in the UK
1 years, 11 months, 2 days
Research summary
The objective of this study is to understand whether ocrelizumab is transferred to the breast milk of women living with Multiple Sclerosis (MS) who are being treated with the drug and if so, what effect this has on babies who are breastfed.
Lay Summary of Results:
The lay Summary is not currently available. As soon as the lay summary is available, it will be shared to the patients by the investigators and will be published in the platform "For patients". CSRs have been submitted to the local authorities and the results are published on the clinicaltrials.gov website.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
21/LO/0647
Date of REC Opinion
21 Sep 2021
REC opinion
Favourable Opinion