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

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04071405

Collaborator

(none)

Enrollment

Locations

28.3

Anticipated Duration (Months)

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ulcerative Colitis	Other: Non-intervention

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).

Study Design

Study Type:

Observational

Anticipated Enrollment :

90 participants

Observational Model:

Case-Only

Time Perspective:

Other

Official Title:

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

Actual Study Start Date :

May 12, 2020

Anticipated Primary Completion Date :

Sep 19, 2022

Anticipated Study Completion Date :

Sep 19, 2022

Outcome Measures

Primary Outcome Measures

Incidence of Adverse Events [Up to 12 months from the time of first treatment]
Adverse Event up to 12 months

Secondary Outcome Measures

General efficacy by the investigator [At 8, 16, 24, 52 weeks after the first treatment]
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
Mayo or partial Mayo Score [At 8, 16, 24, 52 weeks after the first treatment]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country
1	Kyung Hee University Medical Center	Seoul	Korea, Republic of
2	Seoul National University Hospital	Seoul	Korea, Republic of
3	Severance Hospital Sinchon	Seoul	Korea, Republic of