Status: Planned First registered on: 28/02/2020
Last updated on: 05/03/2020
1. Study identification
EU PAS Register NumberEUPAS33879
Official titleMultisource Surveillance Study of Pregnancy and Infant Outcomes in Ocrelizumab-Exposed Women With Multiple Sclerosis
Study title acronymMELODIC Study
Study typeObservational study
Brief description of the studyThis 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.
Was this study requested by a regulator?Yes: EMA, United States
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)Not applicable.
Other study registration identification numbers and URLs as applicableBA39732
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsRTI-HS
Department/Research groupPharmacoepidemiology & Risk Management
Organisation/affiliationRTI Health Solutions
Details of (Primary) lead investigator
Title Dr
Last name Andrea
First name Margulis
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

HealthCore Integrated Research DatabaseSM (HIRD), United States
Countries in which this study is being conducted
International study

Denmark
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed11/09/2017
Start date of data collection30/06/2028
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2030
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesRoche100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Andrea
First name Margulis
Address line 1Av. Diagonal, 605, 9-1
Address line 2 
Address line 3 
CityBarcelona 
Postcode08028 
CountrySpain
Phone number (incl. country code)34932417766 
Alternative phone number 
Fax number (incl. country code)34937608507 
Email address amargulis@rti.org
Public Enquiries
Title Ms 
Last name TISL 
First name Trial Information Support Line 
Address line 1F. Hoffmann-La Roche Ltd. 
Address line 2Grenzacherstrasse 124. 
Address line 3 
CityBasel 
PostcodeCH-4070 
CountrySwitzerland 
Phone number (incl. country code)41616881111 
Alternative phone number 
Fax number (incl. country code) 
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