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NCT03663400 · ClinicalTrials.gov registry record
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
A clinical trial, sponsored by NYU Langone Health.
- Completed
- Registry status
- 47
- Enrollment target
NCT03663400: Completed study, sponsored by NYU Langone Health.
NCT03663400 is a clinical trial that has completed, run by NYU Langone Health. The registered enrollment target is 47 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663400 has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
Study 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.
Primary Outcome
GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients.
Interventions
- DIAGNOSTIC_TEST GWAS analysis by Illumina BeadChip
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2018-12-04 |
| Est. Completion | 2022-03-24 |
What the finished NCT03663400 record still lists
NCT03663400 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which GWAS analysis by Illumina BeadChip is the first listed.
NCT03663400 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03663400 about?
NCT03663400 is a clinical study titled "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". 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 colonosco...
What is the current status of trial NCT03663400?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2018-12-04. Estimated completion is 2022-03-24.
What interventions are being tested in trial NCT03663400?
The interventions under investigation include: GWAS analysis by Illumina BeadChip (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03663400?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
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