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

Study identification

• 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 was a non-interventional observational study designed to evaluate the effectiveness of the belatacept (Nulojix®) Patient Alert Card (PAC) as an additional risk minimization measure in renal transplant patients. The study consisted of three epidemiological sub-studies: (1) a patient survey assessing awareness, distribution, utilization, utility, knowledge, comprehension, and implementation of key safety messages contained in the PAC; (2) a healthcare professional (HCP) survey assessing the same outcomes among nephrologists and nurses; and (3) a Clinical Outcomes Study using retrospective chart review to evaluate whether patients' understanding and implementation of key safety messages were associated with clinical and safety outcomes, particularly serious infections.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

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