Adult patients in the maintenance phase of tofacitinib treatment of ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
This is a prospective, observational, investigator-initiated study with an overarching objective to identify biochemical and genetic markers of patients more likely to flare after tofacitinib dose red
Sponsors
Guy's and St Thomas' NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over, either male or female 2. A history of ulcerative colitis, as defined by standard clinical criteria 3. Patients who are having their tofacitinib dose reduced from 10mg BD to 5mg BD in view of adequate response, as decided by their treating clinical team, and are undergoing routine endoscopy. 4. Sufficient English language skills to understand the patient information sheet and consent form.
Exclusion criteria
Exclusion criteria: 1.Patients undergoing dose reduction for reasons other than adequate response to 10mg bd (ie. active infection or VTE risk). 2. Patients being dose reduced without undergoing endoscopy 3. Patients with insufficient English language skills to understand the patient information sheet and consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At week 44 and at relapse (if applicable): 1. Clinical status (simple clinical colitis activity index and partial Mayo score) 2. C-reactive protein and faecal calprotectin 3. Histological markers of disease activity (Nancy histological index) 4. STAT activation in peripheral blood mononuclear cells 5. Cytokine expression in peripheral T cells 6. Gene signatures in colonic biopsies | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactSailish Honap
Outcome results
None listed