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

Completed

• Conditions: Ulcerative Colitis
• Interventions: Diagnostic Test: GWAS analysis by Illumina BeadChip

• 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

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-09-06
• Study First Posted: 2018-09-10
• Study Start: 2018-12-04
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Total mayo score between 6 and 12
• Endoscopic subscore of 2 or 3

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients Treated with Tofacitinib	GWAS analysis by Illumina BeadChip	Microbiota profiling by 16S sequencing RNA-seq transcriptional profiling of the blood and biopsy samples Immunological profiling by multi-parameter flow cytometry

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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States