Study identification

PURI

https://redirect.ema.europa.eu/resource/33063

EU PAS number

EUPAS28378

Study ID

33063

Official title and acronym

A non-interventional, post-authorization safety study (PASS) to evaluate long-term safety of anakinra (Kineret®) in patients with systemic juvenile idiopathic arthritis

DARWIN EU® study

No

Study countries

Croatia
Denmark
France
Germany
Greece
Hungary
Israel
Italy
Latvia
Netherlands
Norway
Romania
Saudi Arabia
Spain
Switzerland

Study description

An international, non-interventional, single-armed, pharmacovigilance registry study on long-term safety of Kineret utilizing already available data from the ENCePP certified Pharmachild JIA registry.

Study status

Finalised
Research institutions and networks

Institutions

Multiple centres: 20 centres are involved in the study

Networks

Paediatric Rheumatology International Trials Organisation (PRINTO)
Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Ireland
Italy
Latvia
Lithuania
Luxembourg
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
Switzerland
United Kingdom
First published:
06/10/2022
Network
ENCePP partner

Contact details

Ruperto Nicola

Primary lead investigator
Study timelines

Date when funding contract was signed

Actual:

Study start date

Actual:

Data analysis start date

Actual:

Date of final study report

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

More details on funding

Swedish Orphan Biovitrum AB (publ)
Study protocol
Initial protocol

Sobi.ANAKIN-302 Clinical Study Protocol FINAL version 1 13 Mar 2019_Redacted

English (197.21 KB - 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)