Study identification

EU PAS number

EUPAS1000000285

Study ID

1000000285

Official title and acronym

An Observational Study Utilising Data From Big MS Data Registries to Evaluate the Long-Term Safety of Vumerity and Tecfidera

DARWIN EU® study

No

Study countries

Denmark
France
Sweden

Study description

This study’s overall research question and objective is to assess and compare the long-term safety of Vumerity and Tecfidera in participants with newly exposed to treatment, especially with regard to the important potential risks of malignancies and serious and opportunistic infections.

Study status

Ongoing
Research institutions and networks

Institutions

Biogen
First published:
01/02/2024
Institution

Contact details

Study Director

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Biogen-100%
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)