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

28/02/2020
02/07/2024
EU PAS number:
EUPAS33879
Study
Planned
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Study identification

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 institutions and networks

Institutions

RTI Health Solutions (RTI-HS)
France
Spain
Sweden
United Kingdom
United Kingdom (Northern Ireland)
United States
First published:
11/08/2026
Institution Not-for-profit ENCePP partner
HealthCore
First published:
01/02/2024
Institution
Optum
Germany
First published:
07/02/2014
Institution Outdated Other ENCePP partner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
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)