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

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.

Study Overview

• Status: Completed
• Conditions: Ulcerative Colitis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Pfizer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults aged 19 years and older with moderately to severely active ulcerative colitis

Description

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.

  1. Patients with a history of hypersensitivity to any ingredients of this product.
  2. Patients with serious infection (sepsis, etc.) or active infection including localized infection.
  3. Patients with active tuberculosis.
  4. Patients with severe hepatic function disorder.
  5. Patients with an absolute neutrophil count (ANC) <1,000 cells/mm3.
  6. Patients with a lymphocyte count <500 cells/mm3.
  7. Patients with a hemoglobin level <9 g/dL.
  8. Pregnant or possibly pregnant women.
  9. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Other

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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 12, 2020
• Primary Completion (Actual): September 26, 2022
• Study Completion (Actual): September 26, 2022

Study Registration Dates

• First Submitted: August 26, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Immune System Diseases; safety; Autoimmune Diseases; Ulcerative colitis; Tofacitinib; Molecular Mechanisms of Pharmacological Action; Jak inhibitor
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Ulcer; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: A3921343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.