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NCT03663400 Clinical Trial

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

Ulcerative Colitis Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03663400
Other study ID # 18-00630
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 4, 2018
Est. completion date March 24, 2022

Study information
Verified date August 2022
Source NYU Langone Health
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date March 24, 2022
Est. primary completion date March 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• GWAS analysis by Illumina BeadChip
will generate comprehensive genotype data for patients. Samples will be used for transcriptional profiling, microbiota profiling by 16S analysis and immunological profiling by flow cytometry

Locations
Country Name City State
United States New York University School of Medicine New York New York

Sponsors (1)
Lead Sponsor Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary GWAS analysis pretreatment GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients. 1 Day
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