Korea Post-marketing Surveillance for Xeljanz (Registered) in Ulcerative Colitis Patients
NCT04071405
ABOUT THIS STUDY
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Contact a representative by phone, email, or visiting the study website. Please see the references below:
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- Adult ulcerative colitis patients with moderately to severely active disease who has received at least 1 dose of Xeljanz according to the local labeling
- 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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Descriptive Information | |||||
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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 | Recruiting | ||||
Estimated Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers | No | ||||
Contacts |
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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 |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | October 2020 |