Identify Predictors That Distinguish Between Tofacitinib Responders and Non-responders Based on Genotype and Cellular and Molecular Profiles From Pinch Biopsies, Blood and Stool Samples
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT03663400
- Lead Sponsor
- NYU Langone Health
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 47
- Total mayo score between 6 and 12
- Endoscopic subscore of 2 or 3
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GWAS analysis pretreatment 1 Day GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
New York University School of Medicine
🇺🇸New York, New York, United States
New York University School of Medicine🇺🇸New York, New York, United States