Identifying markers of successful dose reduction in the maintenance phase of tofacitinib treatment of ulcerative colitis
Not Applicable
- Conditions
- Adult patients in the maintenance phase of tofacitinib treatment of ulcerative colitisDigestive SystemUlcerative colitis
- Registration Number
- ISRCTN18820528
- Lead Sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
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
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.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> At week 44 and at relapse (if applicable):<br> 1. Clinical status (simple clinical colitis activity index and partial Mayo score)<br> 2. C-reactive protein and faecal calprotectin<br> 3. Histological markers of disease activity (Nancy histological index)<br> 4. STAT activation in peripheral blood mononuclear cells<br> 5. Cytokine expression in peripheral T cells<br> 6. Gene signatures in colonic biopsies<br>
- Secondary Outcome Measures
Name Time Method There are no secondary outcome measures