Study identification

PURI

https://redirect.ema.europa.eu/resource/40211

EU PAS number

EUPAS33879

Study ID

40211

Official title and acronym

Multisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis (MELODIC Study)

DARWIN EU® study

No

Study countries

Denmark
United States

Study description

This will be an observational cohort study of ocrelizumab-exposed pregnancies and two matched comparator cohorts through secondary use of data from multiple sources. The study will be conducted in existing population-based health care databases and registries. The proposed data sources include data from the US and Denmark.

Study status

Planned
Research institution and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
19/02/2024
Institution
Not-for-profitENCePP partner
HealthCore
First published:
01/02/2024
Institution
Optum
Germany
First published:
07/02/2014
Institution
OtherENCePP partner
HealthCore Integrated Research DatabaseSM (HIRD) United States

Contact details

Andrea Margulis

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Roche
Study protocol
Initial protocol

Prot BA39732 OCREVUS v1_Redacted

English (904.19 KB - PDF)View document
Updated protocol

BA39732-protocol-v4-0-2023-03-10-Redacted

English (1.11 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)