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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04071405
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

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
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).

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Study Type : Observational
Estimated 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
Estimated Primary Completion Date : September 19, 2022
Estimated Study Completion Date : September 19, 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: Non-intervention
    Non-intervention observational study


Primary Outcome Measures :
  1. Incidence of Adverse Events [ Time Frame: Up to 12 months from the time of first treatment ]
    Adverse Event up to 12 months


Secondary Outcome Measures :
  1. General efficacy by the investigator [ Time Frame: 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


  2. Mayo or partial Mayo Score [ Time Frame: 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. 1-2 stools more than normal
    2. 3-4 stools more than normal
    3. ≥5 stools more than normal

    B. Rectal bleeding 0: No blood seen

    1. Streaks of blood with stool less than half the time
    2. Obvious blood with stool most of the time
    3. Blood alone passed

    C. Findings of endoscopy 0: Normal or inactive disease

    1. Mild disease (erythema, decreased vascular pattern, mild friability)
    2. Moderate disease (marked erythema, absent vascular pattern, friability, erosion)
    3. Severe disease (spontaneous bleeding, ulceration)

    D. Physician's global assessment 0: Normal

    1. Mild
    2. Moderate
    3. Severe



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adults aged 19 years and older with moderately to severely active ulcerative colitis
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.

    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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04071405


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Kyung Hee University Medical Center Not yet recruiting
Seoul, Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Severance Hospital Sinchon Recruiting
Seoul, Korea, Republic of
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04071405    
Other Study ID Numbers: A3921343
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: June 27, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
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.
Keywords provided by Pfizer:
Ulcerative colitis
Autoimmune Diseases
Immune System Diseases
Tofacitinib
Molecular Mechanisms of Pharmacological Action
Jak inhibitor
safety
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases