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
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
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients with ulcerative colitis treated with XELJANZ
- Patients naive to XELJANZ in the treatment of ulcerative colitis
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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 5, 2022 | ||||
| Estimated Primary Completion Date | January 5, 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 | March 2020 | ||||