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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03663400
Recruitment Status : Recruiting
First Posted : September 10, 2018
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Ulcerative Colitis Diagnostic Test: GWAS analysis by Illumina BeadChip

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Study Type : Observational
Estimated Enrollment : 50 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 : December 4, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Tofacitinib

Group/Cohort 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




Primary Outcome Measures :
  1. GWAS analysis pretreatment [ Time Frame: 1 Day ]
    GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients.


Biospecimen Retention:   Samples With DNA
Microbiota profiling by 16S sequencing RNA seq transcriptional profiling oof blood and biopsy Immunological profiling by multi parameter flow cytometry


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients 18-70 with moderate to severe ulcerative colitis defined as a total mayo score between 6 and 12, and an endoscopic subscore of 2 or 3.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663400


Contacts
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Contact: Ghoncheh Ghiasian, MPH 646-501-7822 Ghoncheh.Ghiasian@nyulangone.org
Contact: Bhavna Sharma, BS Bhavna.Sharma@nyulangone.org

Locations
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United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Ghoncheh Ghiasian       Ghoncheh.Ghiasian@nyulangone.org   
Principal Investigator: David Hudesman, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: David Hudesman, MD NYU Langone Health
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03663400    
Other Study ID Numbers: 18-00630
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Researchers who provide a methodologically sound proposal.

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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:
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Colitis, Ulcerative
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases