Ustekinumab Real World Evidence Study

The purpose of this study is to capture the real-world experience of CD patients treated with ustekinumab as part of their clinical care in a variety of care settings from large teaching/research centres to smaller district hospitals. It will utilise existing research networks to deliver the study effectively. The UK IBD community has strongly demonstrated that it is both willing and able to work on collaborative projects, ranging from interventional trials (TOPPIC, CONSTRUCT) and prospective observational studies (PANTS, VEST), through to case finding studies (PRED4) as well as retrospective cohort studies (UK experience of withdrawal of thiopurines [PMID 25284134] and anti-TNF[PMID 26892328]) as well as the UK IBD BioResource. PANTS successfully recruited from 120 sites in the UK. The study will in part use the UK IBD Registry infrastructure to leverage the impact of the data. These collaborations have led to significant publications in high impact journals, and will impact directly on the management of IBD patients in the near future. Key to this successful work is the National Institute of Health Research (NIHR), which supports local Clinical Research Networks in the delivery of multicentre research.

Inclusion criteria

• Participants being given ustekinumab as part of their routine clinical care
• Any of the following clinical indications:
• CRP of 5mg/L or higher within three months prior to baseline
• Faecal calprotectin of 250mg/L or higher within three months prior to baseline
• Active disease on endoscopy within 6 months prior to baseline
• Switching to ustekinumab because of an AE on another treatment
• Post-operative prophylaxis
• Age 18 or over
• Able to give informed consent
• Able to read English

Exclusion criteria

• Patient is, in the opinion of the investigator, not suitable to participate in the study
• Use of ustekinumab outside of UK SmPC
• Currently enrolled in an IMP/interventional study
• Has received ustekinumab previously