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

NYU Langone Health

Status: Completed

Conditions: Ulcerative Colitis

Treatments: Diagnostic Test: GWAS analysis by Illumina BeadChip

Study type: Observational

Funder types: Other

Identifiers

NCT03663400

18-00630

Details and patient eligibility

About

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.

Enrollment: 47 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

47 participants in 1 patient group

Patients Treated with Tofacitinib

Description:

Microbiota profiling by 16S sequencing RNA-seq transcriptional profiling of the blood and biopsy samples Immunological profiling by multi-parameter flow cytometry

Treatment:

Diagnostic Test: GWAS analysis by Illumina BeadChip