Ocrelizumab Pregnancy Registry

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/35186
• 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:
  Ongoing

Research institution and networks

Institutions

F. Hoffmann-La Roche

1 centre Germany, 2 centres United States

Study timelines

Date when funding contract was signed

Actual: 01/08/2018

Study start date

Planned: 07/10/2019

Actual: 04/11/2019

Date of final study report

Planned: 26/04/2031

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche

Study protocol

Initial protocol

Prot WA40063 OCREVUS v1_Redacted

Updated protocol

Prot WA40063 ocrelizumab v2_Redacted

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

WA40063