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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post Authorization Safety Study, Prospective multicenter multi-national disease registry

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  RUXOLITINIB PHOSPHATE
• Medical condition to be studied:
  Myelofibrosis

Population studied

• Short description of the study population:
  Adult patients with a diagnosis of primary or secondary Myelofibrosis.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  450

Study design details

• Main study objective:
  The primary objective of this Post Authorization Safety Study is to document long-term safety of Ruxolitinib in patients with myelofibrosis in a real-world setting according to the current prescribing information of the European label.
• Outcomes:
  To document the incidence and outcome of events of special interestincluding the following:• bleeding events• serious & opportunistic infections• secondary malignancies• ADRs/ SAEs after discontinuation of Ruxolitinib treatment• pregnancies• deaths of any cause
• Data analysis plan:
  Sponsor personnel or a designated representative will review the data entered by investigational staff for completeness and accuracy. When the data collection process is complete for a patient or at specified time points and the data have been validated, the data are de-identified and moved from the database maintainer to the analysis database of the sponsor. Concomitant medications entered into the database will be coded using the World Health Organization (WHO) Drug Reference List, which employs the Anatomical Therapeutic Chemical (ATC) classification system. Medical history/current medical conditions and adverse events will be coded using the Medical dictionary for regulatory activities (MedDRA) terminology.At the completion of entering data for a patient, the investigator must “electronically certify” or validate that the data for this patient are complete and accurate. At this point, the system will require the investigator to re-enter his password.