Evaluation of the Effectiveness of the Orencia Patient Alert Cards

• Research type

  Research Study

• Full title

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

• IRAS ID

  185325

• Contact name

  Mario Pizzoli

• Sponsor organisation

  Bristol Myers Squibb S.r.l.

• Clinicaltrials.gov Identifier

  ENCEPP/SDPP10122, EU PAS register number ; EMEA/H/C/000701/MEA, Procedure Number

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  Multi-country non-interventional study to assess the effectiveness of the abatacept (ORENCIA©) Patient Alert Card (PAC) in patients with rheumatoid arthritis (RA.
  
  This evaluation is part of the post-marketing commitment to the European Medicines Agency by Bristol-Myers Squibb (BMS),to help improve the PAC.

  To make this evaluation BMS will conduct three sub-studies:

  • Survey to assess understanding and implementation of the PAC in a sample of patients.
  • Survey to assess understanding and implementation of the key safety messages in the PAC among a sample of rheumatologists and nurses.
  • Retrospective chart review study to obtain clinical data to evaluate the correlation of outcomes with patient’s responses ascertained in the patient survey.

  The primary objectives are to collectively evaluate the effectiveness of the PAC by:

  • Assessment of the distribution, awareness, utilisation, utility, knowledge, comprehension and behaviour by patients and healthcare professionals (HCPs).
  • Correlation of measures of the distribution, awareness, utilisation, utility, knowledge, comprehension and behaviour reported by patients, with infection leading to hospitalisation in the same patients.

  Participating countries: UK, France, Germany, Spain, Sweden and Netherlands.

  Population:

  • Patient survey: patients with RA who have been given abatacept within the preceding 3 months.

  • HCP survey: physicians and nurses who have prescribed or managed RA patients with abatacept in the preceding 6 months. HCPs who have been involved in the recruitment of patients for the patient survey will be excluded from the HCP survey.

  • Retrospective chart review study: patients who have completed the patient survey.

  Study size:

  • Patient survey: 400 patients.
  • HCP survey: 80 HCPs (doctors and nurses).
  • Retrospective chart review study: 400 patients.

• REC name

  Yorkshire & The Humber - Bradford Leeds Research Ethics Committee

• REC reference

  16/YH/0052

• Date of REC Opinion

  4 Feb 2016

• REC opinion

  Favourable Opinion