Status:
RECRUITING
NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study
Lead Sponsor:
University of Nottingham
Collaborating Sponsors:
Nottingham University Hospitals NHS Trust
Conditions:
Gastro-Intestinal Disorder
Crohn Disease
Eligibility:
All Genders
16+ years
Brief Summary
The goal of this observational study is to learn about the comparisons of inflammatory markers between IBD and non-IBD (control) participants. The main question it aims to answer is: Are there diffe...
Detailed Description
A cohort study in patients with moderate to severely active Crohns Disease (CD) and Ulcerative Colitis (UC) who are switching to new targeted biologic therapy (with a different mode of action) - onto ...
Eligibility Criteria
Inclusion
- 1\. Provision of signed and dated, written informed consent before any study specific procedures
- AND
- 2a. Patients of at least 16 years of age with active Crohn's disease defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Visible ulcerations on ileocolonoscopy with a total SES-CD \> = 7, or \> = 4 if disease is confined to the terminal ileum OR visable active disease on cross-sectional imaging. Are switching to a new mechanism of action (MOA) onto anti-TNF therapy or ustekinumab or upadacitinib
- OR
- 2b. Patients of at least 16 years (no upper age limit) with active UC defined as: CRP \> = 5 mg/L OR FCP \> = 250 μg/g OR Mayo endoscopy subscore \> = 2. Are switching to a new mechanism of action (MOA) onto either anti-TNFα therapy or vedolizumab
- OR
- 2c. Non-IBD participants who are attending for a lower GI colonoscopy at any participating site. On any hospital/ medical/ clinical screening list or any other appropriate list with no pathology found on examination.
Exclusion
- Inability to give informed consent
- Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
- An ongoing infection requiring treatment
- Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
- Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
- Current diagnosis of cancer
- Having received a solid organ or stem cell transplant
- Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment
- Confirmed pregnancy at time of enrolment
- For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)
- Clinical judgement by the investigator that the patient should not participate in the study
- Under 16yrs of age
Key Trial Info
Start Date :
December 12 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 28 2027
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06956703
Start Date
December 12 2022
End Date
February 28 2027
Last Update
May 29 2025
Active Locations (1)
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1
University of Nottingham
Nottingham, Nottinghamshire, United Kingdom, NG7 2UH