Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/31062
• EU PAS number:
  EUPAS10122
• Study ID:
  31062
• Official title and acronym:
  Evaluation of the effectiveness of the abatacept (ORENCIA®) intravenous and subcutaneous formulation Patient Alert Cards in patients with rheumatoid arthritis in a sample of European Economic Area countries
• DARWIN EU® study:
  No
• Study countries:
  France

  Germany

  Spain

  Sweden

  United Kingdom
• Study description:
  The patient alert cards (PACs) for the use of intravenous (IV) and subcutaneous (SC)formulations of abatacept are to be evaluated as part of the post-marketing commitment to the European Medicines Agency (EMA) by Bristol-Myers Squibb (BMS). Three epidemiological sub-studies will be conducted: a patient survey of understanding and implementation of the key messages in the abataceptPACs, a health care professional (HCP) survey of understanding and implementation of the key messages in the abatacept PACs and 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 PACs.
• Study status:
  Finalised

Research institutions and networks

Institutions

OXON Epidemiology

Spain

United Kingdom

Multiple centres: 40 centres are involved in the study

Study timelines

Date when funding contract was signed

Actual: 05/10/2014

Study start date

Actual: 15/10/2016

Date of final study report

Actual: 07/09/2017

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)?:
  EU RMP category 3 (required)