Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area countries.

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/22739
• EU PAS number:
  EUPAS10046
• Study ID:
  22739
• Official title and acronym:
  Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area countries.
• DARWIN EU® study:
  No
• Study countries:
  Austria

  France

  Germany

  Sweden
• Study description:
  This is a study that evalustes the effectiveness of the belatacept patient alert card (PAC). Three epidemiological sub-studies will be conducted to make this evaluation: a patient survey of understanding and implementation of the key messages in the belatacept PAC, a health care professional (HCP) survey of understanding and implementation of the key messages in the belatacept PAC and a a Clinical Outcomes Study using retrospective chart review to correlate clinical and safety outcomes with levels of understanding and implementation of the key messages in the PAC.
• Study status:
  Finalised

Research institution and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Multiple centres: 20 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 05/08/2014

Actual: 05/08/2014

Study start date

Planned: 01/10/2016

Actual: 01/10/2016

Date of final study report

Planned: 15/01/2018

Actual: 25/01/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Bristol Myers Squibb

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable