Study identification

EU PAS number

EUPAS31342

Study ID

35186

Official title and acronym

Ocrelizumab Pregnancy Registry

DARWIN EU® study

No

Study countries

Germany
United States

Study description

This is a prospective observational registry that will collect primary data from 290 pregnant women with multiple sclerosis (MS) from the United States and Germany, who have been exposed to ocrelizumab during the 6 months prior to their last menstrual period (LMP) or at any time during pregnancy, and 290 pregnant women who have not been exposed to ocrelizumab.
Frequency of exposed pregnancy outcomes will be compared with the unexposed group and with available background prevalence from external comparators, namely the Metropolitan Atlanta Congenital Defects Program(MACDP) and the European Surveillance of Congenital Anomalies (EUROCAT).

Study status

Finalised
Research institutions and networks

Institutions

1 centre Germany, 2 centres United States

Contact details

Erwan Muros

Primary lead investigator

Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Roche
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Not applicable