Xeljanz Special Investigation for Long-term Use in UC Patients
NCT03643211
Last updated date
ABOUT THIS STUDY
Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under
Japanese medical practice
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Ulcerative Colitis
Sex
Females and Males
Age
0 +
Inclusion Criteria
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- Patients with ulcerative colitis treated with XELJANZ
- Patients naive to XELJANZ in the treatment of ulcerative colitis
Exclusion Criteria
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- None
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Advanced Information
Descriptive Information | |||||
---|---|---|---|---|---|
Brief Title | Xeljanz Special Investigation for Long-term Use in UC Patients | ||||
Official Title | XELJANZ(REGISTERED) TABLETS 5 MG SPECIAL INVESTIGATION(INVESTIGATION OF LONG-TERM USE IN PATIENTS WITH ULCERATIVE COLITIS) | ||||
Brief Summary | Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice | ||||
Detailed Description | This investigation aims to examine the safety and effectiveness of Xeljanz in post-marketing clinical settings when it is administered chronically to patients with ulcerative colitis, based on the approval conditions. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | UC patients who were confirmed to have received Xeljanz after the approval date of dosage and administration of Xeljanz for UC patients | ||||
Condition | Ulcerative Colitis | ||||
Intervention | Not Provided | ||||
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 | Active, not recruiting | ||||
Actual Enrollment | 1 | ||||
Original Estimated Enrollment | 500 | ||||
Estimated Study Completion Date | January 11, 2022 | ||||
Estimated Primary Completion Date | January 11, 2022 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria: - None | ||||
Sex/Gender |
| ||||
Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Japan | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT03643211 | ||||
Other Study ID Numbers | A3921248 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
| ||||
Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
| ||||
PRS Account | Pfizer | ||||
Verification Date | April 2021 |