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
- Observational
- Recruiting
- NCT03663400
Contact Information
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
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.
Gender
All
Age Group
18 Years to 70 Years
Accepting Healthy Volunteers?
No
- 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.