Status: Ongoing First registered on: 06/07/2017
Last updated on: 29/03/2019
1. Study identification
EU PAS Register NumberEUPAS19800
Official titleAn observational study utilising data from the US Tysabri TOUCH programme and select EU MS Registries to estimate the risk of progressive multifocal leukoencephalopathy (PML) and other serious opportunistic infections among patients who were exposed to an MS disease modifying treatment prior to treatment with Tysabri
Study title acronym
Study typeObservational study
Brief description of the studyThe primary purpose of this study is to estimate the incidence of progressive multifocal leucoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs), including newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate). Researchers will also look to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs (including fingolimod, dimethyl fumarate and teriflunomide) and the established DMTs (interferon beta and glatiramer acetate)
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)
Other study registration identification numbers and URLs as applicable101MS411 Clinicaltrials.gov ID: NCT03399981, Clinicaltrials.gov URL:https://clinicaltrials.gov/ct2/show/NCT03399981?id=101ms411&rank=1
2. Research centres and Investigator details
Coordinating study entity
Centre nameBiogen
Centre locationUnited States
Details of (Primary) lead investigator
Title Dr
Last name Biogen
First name Study Director
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

Denmark
France
Germany
Sweden
United Kingdom
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/12/201605/12/2016
Start date of data collection03/10/201701/06/2017
Start date of data analysis
Date of interim report, if expected
Date of final study report30/06/2024
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesBiogen100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Biogen
First name Study Director
Address line 1250 Binney Street
Address line 2 
Address line 3 
CityCambridge, MA 
Postcode02142 
CountryUnited States
Phone number (incl. country code)017814642000 
Alternative phone number 
Fax number (incl. country code) 
Email address clinicaltrials@biogen.com
Public Enquiries
Title Mr 
Last name Biogen 
First name Clinical Trial Transparency 
Address line 1250 Binney Street 
Address line 2 
Address line 3 
CityCambridge, MA 
Postcode02142 
CountryUnited States 
Phone number (incl. country code)017814642000 
Alternative phone number 
Fax number (incl. country code) 
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