Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Study Overview
=================
Brief Summary
-----------------
As required for new medications approved by the Ministry of Food and Drug Safety, safety and efficacy information should be provided for a minimum of 90 patients treated in the setting of routine practice during 4 years following approval (until 19 September 2022). Out of all the enrolled patients, at least 18 cases (20%) will be followed up until the 52nd week to see the long term safety of Xeljanz.

Detailed Description
-----------------
This is an open-label, non-comparative, non-interventional, prospective, and multi-center study conducted in Korean health care centers by accredited physicians (ie, investigators). The study population will be adult patients with moderately to severely active UC who have had an inadequate response or intolerance to the basic treatments or biological agents. Clinical Severity of Ulcerative Colitis is classified as mild, moderate, or severe based on the Mayo score or partial Mayo score. Xeljanz will be administered according to the Dosage and Administration of the approved labeling. There is no visit or activity mandated by this study. The investigator will collect patient data and record the information on each patient's case report form (CRF).

Official Title
-----------------
Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Other: Non-intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling Exclusion Criteria: Patients meeting any of the following criteria as per local labeling will not be included in the study. Patients with a history of hypersensitivity to any ingredients of this product. Patients with serious infection (sepsis, etc.) or active infection including localized infection. Patients with active tuberculosis. Patients with severe hepatic function disorder. Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3. Patients with a lymphocyte count <500 cells/mm3. Patients with a hemoglobin level <9 g/dL. Pregnant or possibly pregnant women. Because of lactose contained in this drug, it should not be administered to patients with hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose galactose malabsorption.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Non-intervention|Non-intervention observational study|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events | Adverse Event up to 12 months | Up to 12 months from the time of first treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| General efficacy by the investigator | General efficacy will be determined into 4 categories by the investigator based on clinical impression and patient's Mayo or partial Mayo score. The 4 categories are as follows Improved : Symptoms of ulcerative colitis have improved or showed adequate maintenance effect after taking Xeljanz Unchanged : Symptoms have not changed much since taking Xeljanz Aggravated : Symptoms have worsened after taking Xeljanz Not assessible : Reason written down seperately | At 8, 16, 24, 52 weeks after the first treatment | 
| Mayo or partial Mayo Score | Mayo score or partial Mayo score is calculated. Mayo Score is defined as sum of the following scores. Partial Mayo score excludes findings of endoscopy. A. Stool frequency 0 : Normal number of stool 1-2 stools more than normal 3-4 stools more than normal ≥5 stools more than normal B. Rectal bleeding 0: No blood seen Streaks of blood with stool less than half the time Obvious blood with stool most of the time Blood alone passed C. Findings of endoscopy 0: Normal or inactive disease Mild disease (erythema, decreased vascular pattern, mild friability) Moderate disease (marked erythema, absent vascular pattern, friability, erosion) Severe disease (spontaneous bleeding, ulceration) D. Physician's global assessment 0: Normal Mild Moderate Severe | At 8, 16, 24, 52 weeks after the first treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colitis, Autoimmune Diseases, Immune System Diseases, Tofacitinib, Molecular Mechanisms of Pharmacological Action, Jak inhibitor, safety