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
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 1/12/2019 |
| Start Date: | December 4, 2018 |
| End Date: | October 2019 |
| Contact: | Gregory Pappas |
| Email: | Gregory.Pappas@nyumc.org |
| Phone: | (212) 263-3095 |
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.
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.
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.
We found this trial at
1
site
550 1st Ave
New York, New York 10016
New York, New York 10016
(212) 263-7300
Principal Investigator: David Hudesman, MD
Phone: 212-263-3095
New York University School of Medicine NYU School of Medicine has a proud history that...
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