A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO

Study identification

• EU PAS number:
  EUPAS22954
• Study ID:
  42481
• Official title and acronym:
  A multi-centre observational study to describe the impact of vedolizumab on concomitant prescribing and quality of life in patients with ulcerative colitis and Crohn’s disease in the UK and Ireland: OCTAVO
• DARWIN EU® study:
  No
• Study countries:
  Ireland

  United Kingdom
• Study description:
  This is a part retrospective, part prospective, multi-center, observational study for patients with ulcerative colitis (UC) or Crohn’s disease (CD). The study will review the medical records of patients to provide real-world evidence related to the impact of vedolizumab on corticosteroid, immunomodulator and antibiotic prescribing. In the retrospective cohort, the study will evaluate the extent of corticosteroid prescribing amongst patients with UC initiated on vedolizumab compared with patients initiated on an anti-tumor necrosis factor alpha (anti-TNFα) agent. In a separate prospective cohort, the study will evaluate the impact of vedolizumab on the health related quality of life (HRQoL) of patients with UC or CD during the first 12 months following initiation of vedolizumab. The study will have two cohorts: Cohort 1 and Cohort 2. Patients with UC who received either vedolizumab or an anti-TNF as first-line biologic therapy as part of standard clinical practice in the United Kingdom (UK) will be recruited to Cohort 1. Patients with UC or CD who are being initiated on medical treatment with vedolizumab under standard clinical practice in the UK and Ireland will be recruited to Cohort 2. The overall time to collect patients’ retrospective data related to outcome measures and baseline characteristics in Cohort 1 is approximately 9 months. In Cohort 2, patients will be recruited over 4 months and HRQoL will be collected prospectively, with patient characteristics data to be collected at baseline.
• Study status:
  Finalised

Research institutions and networks

Institutions

St Mark’s Hospital, London North West Healthcare NHS Trust England, Bristol Royal Infirmary, University Hospitals Bristol NHS Foundation Trust England, Manchester Royal Infirmary, Central Manchester University Hospitals NHS Foundation Trust England, Western General Hospital, NHS Lothian England, Mercy University Hospital, Cork (Cohort 2 only) Republic of Ireland

Study timelines

Date when funding contract was signed

Planned:16/03/2017

Actual:16/03/2017

Study start date

Planned:29/06/2018

Actual:10/07/2018

Data analysis start date

Planned:20/07/2020

Actual:13/08/2020

Date of final study report

Planned:23/12/2020

Actual:18/12/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Takeda

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable