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NCT03772145 · ClinicalTrials.gov registry record
Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study
A clinical trial, sponsored by University of North Carolina, Chapel Hill.
- Terminated
- Registry status
- 103
- Enrollment target
NCT03772145: Clinical Trial study, sponsored by University of North Carolina, Chapel Hill.
NCT03772145 is a clinical trial that was terminated before completion, run by University of North Carolina, Chapel Hill. The registered enrollment target is 103 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03772145 was terminated before completion, sponsored by University of North Carolina, Chapel Hill.
- TERMINATED
- Registry status
- 103 participants
- Enrollment target
Study Summary
The overarching goal of this study, is to create a longitudinally followed, well phenotyped cohort of patients with UC starting treatment with tofacitinib in the setting of standard of care who have linked clinical data and self-reported outcome data that will lead to evaluation of efficacy and safety of tofacitinib in the real-life setting. The specific aims for the study are: 1. Create a prospective cohort of well phenotyped (proctitis vs. rectosigmoiditis vs. extensive) adult UC patients with serial clinical and patient-reported data collected throughout the course of 12 months of tofacitinib therapy. Enrolled patients on therapy will be followed up to 36 months after the start of therapy. 2. To determine clinical response rates and persistence of therapy with tofacitinib for induction and maintenance therapy 3. Describe the incidence of specific drug-associated adverse events (shingles, serious infections), hospitalizations and surgeries in the standard of care setting. 4. Assess the correlation of various outcome measures in ulcerative colitis (Simple Clinical Colitis Activity Index (SCCAI), partial Mayo index, 6-point index) and endoscopic outcomes via the endoscopic Mayo Score
Primary Outcome
Clinical response as assessed by the Simple Clinical Colitis Activity Index (SCCAI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2024-01-29 |
Why NCT03772145 stopped before completion
NCT03772145 is an observational study that tracks outcomes without assigning an intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT03772145 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03772145 about?
NCT03772145 is a clinical study titled "Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study". The overarching goal of this study, is to create a longitudinally followed, well phenotyped cohort of patients with UC starting treatment with tofacitinib in the setting of standard of care who have linked clinical data and self-reported outcome data that will lead to evaluation of efficacy and safe...
What is the current status of trial NCT03772145?
This trial is currently terminated. The enrollment target is 103 participants. The study started on 2018-11-27. Estimated completion is 2024-01-29.
Who is sponsoring clinical trial NCT03772145?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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