Status: Ongoing First registered on: 28/02/2019
Last updated on: 12/09/2019
1. Study identification
EU PAS Register NumberEUPAS28619
Official titleLong-Term Surveillance of Ocrelizumab Treated Patients With Multiple Sclerosis
Study title acronymMANUSCRIPT Study
Study typeObservational study
Brief description of the studyThis longitudinal observational study is part of the European Union (E.U.) risk management plan and is designed to further assess the long-term safety profile of ocrelizumab in the real world setting. The study will provide safety data for a 10 year period after ocrelizumab launch, specifically targeting the rate of SAEs, including serious infections and malignancies.
Was this study requested by a regulator?No
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)
Other study registration identification numbers and URLs as applicableBA39730
2. Research centres and Investigator details
Coordinating study entity
Centre nameF. Hoffmann-La Roche Ltd
Centre locationSwitzerland
Details of (Primary) lead investigator
Title Dr
Last name Wormser
First name David
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

Australia
Denmark
France
Germany
Italy
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/2017
Start date of data collection01/08/201915/07/2019
Start date of data analysis14/04/2028
Date of interim report, if expected
Date of final study report31/01/2029
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesF. Hoffmann-La Roche100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Wormser
First name David
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) 
Email address global.clinical_trial_registry@roche.com
Public Enquiries
Title Mr 
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) 
Email address global.clinical_trial_registry@roche.com 
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