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Clinical Trial Summary

This is a prospective cohort study enrolling ulcerative colitis patients who initiate tofacitinib therapy. Investigators will collect clinical data, blood and stool samples prior to initiation of tofacitinib and, at minimum, monthly after the start of therapy. They will collect tissue from colonoscopies prior to initiation of therapy and within 6 months on therapy. Clinical characteristics and response to treatment will then be associated with genotype, blood immune profiles, stool microbiota, and cellular and molecular profiles of the biopsies to generate a treatment response model. Using predictors identified in our model, we will then attempt to validate the model and findings with the OCTAVE (Pfizer), SPARC (CCF), and RISK (CCF) data.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT03663400
Study type Observational
Source NYU Langone Health
Contact
Status Completed
Phase
Start date December 4, 2018
Completion date March 24, 2022

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