UndieS: Ustekinumab Real World Evidence Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 601
- Locations
- 22
- Primary Endpoint
- Steroid-free remission
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Steroid-free remission
Time Frame: One year
Steroid-free remission at one year as defined by a mHBI at week 56 of less than or equal to 4.
Secondary Outcomes
- Description of the demographics, disease phenotype, disease history, treatment history and concomitant medication use of patients receiving ustekinumab.(Two years)
- Remission and response rates(Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped)
- Drug persistence(Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped)
- 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)
- 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)
- Tolerance and safety of ustekinumab(Week 8, Week 14/16, Week 56, Week 82, Week 108 or until treatment stopped)