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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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03663400
Collaborator
(none)
47
Enrollment
1
Location
39.6
Actual Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GWAS analysis by Illumina BeadChip

Study Design

Study Type:
Observational
Actual Enrollment :
47 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Dec 4, 2018
Actual Primary Completion Date :
Mar 24, 2022
Actual Study Completion Date :
Mar 24, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients Treated with Tofacitinib

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

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

Outcome Measures

Primary Outcome Measures

  1. GWAS analysis pretreatment [1 Day]

    GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 New York University School of Medicine New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: David Hudesman, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT03663400
Other Study ID Numbers:
  • 18-00630
First Posted:
Sep 10, 2018
Last Update Posted:
Aug 12, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Colitis
Colitis, Ulcerative

Study Results

No Results Posted as of Aug 12, 2022