A non-interventional, post authorization safety study (PASS) to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe. Sobi.Anakin-201 (PASS Kineret CAPS)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/33224
• EU PAS number:
  EUPAS6366
• Study ID:
  33224
• Official title and acronym:
  A non-interventional, post authorization safety study (PASS) to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with regard to serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe. Sobi.Anakin-201 (PASS Kineret CAPS)
• DARWIN EU® study:
  No
• Study countries:
  France

  Netherlands

  United Kingdom
• Study description:
  A non-interventional, post authorization safety study (PASS) to evaluate the safety of Kineret in the treatment of Cryopyrin Associated Periodic Syndromes (CAPS) in routine clinical care with focus on serious infections, malignancies, injection site reactions, allergic reactions and medication errors, including re-use of syringe
• Study status:
  Finalised

Research institution and networks

Institutions

IRCCS Istituto Giannina Gaslini, Pediatric Rheumatology International Trials Organisation (PRINTO)

Italy

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

Study timelines

Date when funding contract was signed

Planned: 01/10/2014

Actual: 01/10/2014

Study start date

Planned: 15/10/2014

Actual: 15/10/2014

Data analysis start date

Planned: 04/05/2015

Actual: 04/05/2015

Date of interim report, if expected

Planned: 30/06/2015

Actual: 30/06/2015

Date of final study report

Planned: 30/06/2020

Actual: 13/11/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Swedish Oprhan Biovitrum

Study protocol

Initial protocol

PASS protocol Sobi.Anakin-201_v1_10JUN2014

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)