Study identification

PURI

https://redirect.ema.europa.eu/resource/48270

EU PAS number

EUPAS19800

Study ID

48270

Official title and acronym

An 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

DARWIN EU® study

No

Study countries

United States

Study description

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). 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)

Study status

Finalised
Research institutions and networks

Institutions

Biogen
First published:
01/02/2024
Institution

Contact details

Study Director Biogen

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Biogen
Study protocol
Initial protocol

101MS411 Protocol V2 Final 26Jan2022_Redacted.pdf

English (1.09 MB - PDF)View document
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)