Ulcerative Colitis
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TESTGWAS analysis by Illumina BeadChip
will generate comprehensive genotype data for patients. Samples will be used for transcriptional profiling, microbiota profiling by 16S analysis and immunological profiling by flow cytometry
Sponsors
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Total mayo score between 6 and 12 * Endoscopic subscore of 2 or 3
Exclusion criteria
* Recent use of antibiotic therapy (\<4 weeks) * Current extreme diet (parenteral nutrition, specific carbohydrate diet). * Active infection or malignancy. * Significant underlying liver or renal disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GWAS analysis pretreatment | 1 Day | GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients. |
Countries
United States
Outcome results
None listed