Study identification

PURI

https://redirect.ema.europa.eu/resource/46161

EU PAS number

EUPAS28580

Study ID

46161

Official title and acronym

TOP: Tysabri® Observational Program

DARWIN EU® study

No

Study countries

Argentina
Australia
Belgium
Canada
Czechia
Finland
France
Germany
Greece
Italy
Mexico
Netherlands
Norway
Portugal
Slovakia
Spain
United Kingdom

Study description

The primary objective of this study is to assess the long-term safety and impact on disease activity and progression of natalizumab in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

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

Actual:

Study start date

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

IMA-06-02 Protocol V9 Final 28NOV2022_Redacted.pdf

English (368.12 KB - PDF)View document
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)