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

NCT04071405

Last updated date
Study Location
Kyung Hee University Medical Center
Seoul, , , Korea, Republic of
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

By email

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ulcerative Colitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
Official Title Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
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 600 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 120 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).
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Adults aged 19 years and older with moderately to severely active ulcerative colitis
Condition Ulcerative Colitis
Intervention Other: Non-intervention
Non-intervention observational study
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: August 26, 2019)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 19, 2022
Estimated Primary Completion Date September 19, 2022   (Final data collection date for primary outcome measure)
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.

    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.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT04071405
Other Study ID Numbers A3921343
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date June 2020