An open label exploratory analysis of blood, stool and the histological and immunological changes of the colonic mucosa during treatment with tofacitinib for moderate to severe ulcerative colitis
Completed
- Conditions
- lcerative colitis<br />Colitis ulcerosa
- Registration Number
- NL-OMON25297
- Lead Sponsor
- niversity Center Amsterdam (AMC)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Inclusion Criteria
1.Subject must be at least 18 years of age.
2.Males and females with a documented diagnosis of UC ≥ 4 months prior to entry into the study. A biopsy report supporting the diagnosis must be available in the source documents.
Exclusion Criteria
1.Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn’s disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the efficacy of twice daily doses of tofacitinib (10 mg bid) to decrease histological inflammation after 8 weeks of treatment in patients with moderate to severely active ulcerative colitis measured by:<br /><br>Median change in inflammatory infiltrates at week 8 in 2 colon biopsies as assessed by the Robarts Histopathology Index [Mosli, Gut, 2015] and the Geboes index [Geboes, Gut, 2000], by an independent GI pathologist. <br>
- Secondary Outcome Measures
Name Time Method