Crohn's Disease
Conditions
Keywords
Inflammatory Bowel Disease
Brief summary
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.
Detailed description
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.
Interventions
DRUGUstekinumab
Intravenous baseline, subcutaneous follow ups.
Sponsors
University Hospital Southampton NHS Foundation Trust
Liverpool University Hospitals NHS Foundation Trust
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Steroid-free remission | One year | Steroid-free remission at one year as defined by a mHBI at week 56 of less than or equal to 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Description of the demographics, disease phenotype, disease history, treatment history and concomitant medication use of patients receiving ustekinumab. | Two years | Collected from medical records and patient |
| Remission and response rates | Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped | Response to treatment as measured by modified Harvey Bradshaw Index (mHBI) |
| Drug persistence | Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped | Enquiring of the patient whether they are still administering the treatment at each follow up visit |
| Patient experience of ustekinumab as assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) | Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped | Multiple choice questionnaire about patient's experience of using the medication |
| Effect of ustekinumab on disease activity as measured by routinely collected biomarkers | Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped | Review of existing blood samples, and calprotectin results, done as part of routine care |
| Tolerance and safety of ustekinumab | Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped | Review of adverse events as reported by the patient at each study visit |
Countries
United Kingdom
Outcome results
None listed