Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GWAS analysis by Illumina BeadChip | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| GWAS analysis pretreatment | GWAS analysis by Illumina BeadChip to generate comprehensive genotype data on all 50 patients. | 1 Day |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Hudesman, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
All of the individual participant data collected during the trial, after deidentification.
Beginning 3 months and ending 5 years following article publication.
Researchers who provide a methodologically sound proposal.
Not provided
Not provided
Not provided
Not provided
Not provided
Microbiota profiling by 16S sequencing RNA seq transcriptional profiling oof blood and biopsy Immunological profiling by multi parameter flow cytometry
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided