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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04071405
• Other study ID #: A3921343
• Status: Completed
• Start date: May 12, 2020
• Est. completion date: September 26, 2022

Study information

• Verified date: November 2022
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 26, 2022
• Est. primary completion date: September 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Other:
• Non-intervention
Non-intervention observational study

Locations

Country	Name	City	State
Korea, Republic of	Pfizer	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Adverse Events	Adverse Event up to 12 months	Up to 12 months from the time of first treatment
Secondary	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
Secondary	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

External Links

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