Study identification

EU PAS number

EUPAS28992

Study ID

36709

Official title and acronym

A Multicenter, Open-Label Safety Study of Natalizumab administered to Subjects with Relapsing Forms of Multiple Sclerosis who participated in STRATA

DARWIN EU® study

No

Study countries

Belgium

Study description

The primary objective for this study is long-term safety (incidence and pattern of serious adverse events) in subjects receiving natalizumab.The secondary objective is to evaluate the long-term efficacy of natalizumab in delaying the progression of disability, reducing the frequency of relapses, decreasing the disease activity observed by magnetic resonance imaging (MRI), and the evaluation of the quality of life and cognitive function in patients on treatment with natalizumab for more than 8 years.

Study status

Finalised
Research institutions and networks

Institutions

Biogen
First published:
01/02/2024
Institution
Multiple centres: 4 centres are involved in the study

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

Actual:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Biogen
Regulatory

Was the study required by a regulatory body?

No

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

Non-EU RMP only