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Tofacitinib Response in Ulcerative Colitis - a Real World Prospective Multi-center Study

TerminatedN/A

Sponsor: University of North Carolina, Chapel Hill

Conditions: Ulcerative Colitis

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

1. Adult patients, age 18 years or older, with UC, who within 2 weeks have been started on tofacitinib therapy for moderate to severe UC or who plan to start this therapy within the next 2 weeks. The start of the tofacitinib therapy must have been or be initiated in the setting of standard of care therapy
2. Anticipation that the patient will be followed by the participating center at least for the next 12 months
3. Diagnosis of UC must be established on the basis of standard clinical, radiographic, endoscopic, and histologic criteria as described below.

Exclusion Criteria:

* 1\. Patients will be excluded if they meet any of the following criteria:

  1. Inability to provide informed consent
  2. Patients presenting for a one-time consultation

Locations (1)

Chapel Hill, North Carolina, United States