Golimumab Utilisation And Impact in Patients with AS

• Research type

  Research Study

• Full title

  Golimumab: A UK Two-part Observational Study Of Its Utilisation And Impact in Patients with Ankylosing Spondylitis

• IRAS ID

  189145

• Contact name

  Helen Cardy

• Contact email

  helencardy@phassociates.com

• Sponsor organisation

  Merck Sharpe & Dohme Ltd.

• Duration of Study in the UK

  0 years, 10 months, 29 days

• Research summary

  This is a UK multicentre, non-interventional study of golimumab in patients with ankylosing spondylitis (AS). AS treatment and resource use is an under-researched area and this study will address this, with a specific focus on patients with AS who are treated with golimumab. Golimumab is a type of drug known as a tumour necrosis factor (TNF)-α inhibitor, which is used to help reduce inflammation and pain.

  The study is designed in two parts which will be run simultaneously:
  Part 1: Retrospective data collection
  A retrospective chart review will be performed to collect data on the 12 months pre- and 12 months post-golimumab initiation for patients who started golimumab at least 12 months ago.

  Retrospective data for part 1 of the study will be collected either by members of the direct care team or by trained external researchers. Where external researchers are collecting data from medical records, patients will provide written informed consent for a researcher to access their medical records. Where data collection will be completed by members of the direct care team, patient consent is not required for the release of anonymised-coded data. Relatives of deceased patients will not be approached for consent since for these patients, data will be collected by members of the direct clinical care team.

  Part 2: Patient-reported data collection
  Prospective patient-reported data (telephone interviews and postal questionnaires) will be collected for 6 months from patients newly-initiated on golimumab (and will also involve retrospective data recall of the 6 months pre-golimumab initiation).

  Approximately 100 patients will be recruited into Part 1 and 30 patients into Part 2 of the study. The study will be undertaken in six UK secondary care rheumatology centres.

• REC name

  East of England - Essex Research Ethics Committee

• REC reference

  15/EE/0391

• Date of REC Opinion

  12 Oct 2015

• REC opinion

  Favourable Opinion