NAZA - Nottingham/Astra ZenecA Prospective IBD Cohort Study

Korábbi kezelés

• Participation in a clinical study with pharmacological intervention within 3 months prior to Baseline visit.
• Having received a solid organ or stem cell transplant
• For non-IBD participants: A prior history of IBD (CD, UC, microscopic colitis, indeterminate colitis or IBD unspecified)

Más betegség

• An ongoing infection requiring treatment
• Clinical evidence of active COVID infection and/or evidence of active COVID determined by local standard care procedures
• Current diagnosis of cancer

Laborértékek

• Any positive result from previous screening for serum hepatitis B surface antigen, hepatitis C or human immunodeficiency virus (HIV)
• Having received a transfusion of blood, plasma, or platelets within 120 days prior to enrolment

Életkor

• Under 16yrs of age

Egyéb

• Inability to give informed consent
• Confirmed pregnancy at time of enrolment
• Clinical judgement by the investigator that the patient should not participate in the study

• 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.