Status: Ongoing
First registered on:
23/01/2018
Last updated on:
09/08/2023
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
National study
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 collection24/01/201801/06/2017
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)
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)
6. Study drug(s) information
Not applicable (disease/epidemiology study)
7. Medical conditions to be studied
Medical condition(s)Yes
Progressive multifocal leukoencephalopathy
Multiple sclerosis
8. Population under study
Age
Preterm newborns
Term newborns (0-27 days)
Infants and toddlers (28 days - 23 months)
Children (2 - 11 years)
Adolescents (12 - 17 years)
Adults (18 - 44 years)
Adults (45 - 64 years)
Adults (65 - 74 years)
Adults (75 years and over)
Sex
Male
Female
9. Number of subjects
Estimated total number of subjects80327
Additional information
1754 from prior fingolimod treatment, 4077 From prior DMF treatment, 3618 from prior teriflunomide treatment, 64,000 from prior interferon beta and glatiramer acetate.
10. Source of data
Is this study being carried out with an established data source?Yes
Data sources not registered with ENCePP
TOUCH registry, United States
OFSEP: l’Observatoire Français de la Sclérose en Plaques, France
NTD: NeuroTransData, Germany
DSMR: Danish MS Registry, Denmark
SMSreg: Swedish MS Registry, Sweden
Sources of data
Disease/case registry
11. Scope of the study
What is the scope of the study?
Risk assessment
Primary scope : Risk assessment
12. Main objective(s)
What is the main objective of the study?
The 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).
Are there primary outcomes?Yes
To estimate the incidence of progressive multifocal leucoencephalopathy (PML) among patients who switched to Tysabri from disease modifying therapies (DMTs) and to estimate the incidence of other serious opportunistic infections among patients who switch to Tysabri from newer DMTs and the established DMTs
Are there secondary outcomes?No
13. Study design
What is the design of the study?
Patient Registry Study
14. Follow-up of patients
Will patients be followed up?Not applicable/no follow-up
15. Data analysis plan
Please provide a brief summary of the analysis method
Risk Estimation
16. ENCePP seal
Are you requesting the ENCePP seal for this study?
No
17. Full protocol
Available when the study ends
18. Study Results
Not submitted
Please list the 5 most relevant publications using data from your study
ReferenceLink to web-publication
None
19. Other relevant documents
Conflict(s) of interest of
investigator(s)Not submitted
Composition of Steering Group and
ObserversNot submitted
Other documentsNot
submitted
Signed Code of
Conduct Checklist
Not submitted
Signed Code of Conduct Declaration
Not submitted
Signed Checklist for Study
Protocols
Not submitted
