A Non Interventional Long term safety Study of Ruxolitinib in Myelofibrosis (JAKAVI)

Study identification

• EU PAS number:
  EUPAS3296
• Study ID:
  29298
• Official title and acronym:
  A Non Interventional Long term safety Study of Ruxolitinib in Myelofibrosis (JAKAVI)
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Italy

  Netherlands

  Switzerland

  United Kingdom
• Study description:
  This is a Post Authorization Safety Study according to the EU Volume 9a of the Rules Governing Medicinal Products in the European Union and is planned as a prospective, multicenter,Multi-national disease registry for patients diagnosed with myelofibrosis. The study is planned to recruit patients diagnosed with MF exposed and non-exposed to Ruxolitinib with the objective of enrolling at least 300 patients exposed to ruxolitinib within 2 years. It is expected that about 150 patients not exposed to Ruxolitinib will be recruited during the enrolment period. A minimum follow-up of at least 3 years will be allowed for all patients enrolled.
• Study status:
  Finalised

Research institutions and networks

Institutions

Novartis Pharmaceuticals

Boehringer Ingelheim Pharma GmbH&Co.KG

Multiple centres: 53 centers are involved in the study

Study timelines

Date when funding contract was signed

Planned:24/09/2012

Actual:24/09/2012

Study start date

Planned:31/01/2013

Actual:03/06/2013

Data analysis start date

Planned:01/07/2018

Actual:05/07/2018

Date of final study report

Planned:10/12/2018

Actual:19/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novartis Pharmaceuticals

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)