A study to describe the impact of AbbVie Care

• Research type

  Research Study

• Full title

  A real world study to describe the impact of AbbVie Care on patient quality of life and experience and NHS resource use in inflammatory bowel disease, rheumatoid arthritis, psoriasis, psoriatic arthritis and ankylosing spondylitis in the UK (AMORE)

• IRAS ID

  211096

• Contact name

  Matthew Brookes

• Contact email

  matthew.brookes@nhs.net

• Sponsor organisation

  Abbive Ltd

• Duration of Study in the UK

  1 years, 6 months, 1 days

• Research summary

  This observational study will be performed with a prospective and retrospective, non-interventional, multi-centre design in the UK only. 10 sites in the UK will take part.

  Two cohorts of patients will be included:

  For cohort 1 (i.e. adult patients receiving AbbVie Care) approximately 50 patients from each of the five therapeutic indications for which AbbVie Care is offered will be recruited into the study, with a total of 250 patients in cohort 1 overall.
  For cohort 2, (i.e. adult patients from the participant sites, who were initiated on adalimumab for the same indications as cohort 1, prior to the availability of AbbVie Care) 250 patients (approximately 50 per indication) will be included as historical matched controls.
  Thus the study will include data from 500 patients overall, consisting of 50 patients per disease per cohort.
  The therapeutic areas are: inflammatory bowel disease, rheumatoid arthritis, psoriasis, psoriatic arthritis and ankylosing spondylitis.

  Patients in cohort 1 will be asked to complete questionnaires to assess quality of life at baseline (enrollment into AbbVie Care), and then at 3, 6, 9 and 12 months for comparison against the baseline.
  In addition, retrospective data will be collected from medical records of both cohort 1 and 2 on healthcare resource use, demographics, treatment history, disease and medical history, for comparison between the two cohorts.

  All data will be provided in a pseudonymised form to researchers for data management, analysis and reporting.
  Analyses will be both descriptive and comparative in nature.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  16/NE/0311

• Date of REC Opinion

  14 Sep 2016

• REC opinion

  Further Information Favourable Opinion