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
Eligibility Details Visit Clinicaltrials.gov

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

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.

At a Glance

National Government IDNCT03663400

IRB#CIRB18-0685

Lead SponsorNYU Langone Health

Lead PhysicianJoel Pekow

Collaborator(s)N/A

EligibilityAll
18 Years to 70 Years
Recruiting