Xeljanz Special Investigation for Long-term Use in UC Patients

NCT03643211

Last updated date
Study Location
Pfizer Local Country Office
Tokyo, , , Japan
Contact
1-800-718-1021

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

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[email protected]

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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
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
 (submitted: February 25, 2020)
1
Original Estimated Enrollment
 (submitted: August 21, 2018)
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:

  • Patients with ulcerative colitis treated with XELJANZ
  • Patients naive to XELJANZ in the treatment of ulcerative colitis

Exclusion Criteria:

- None

Sex/Gender
Sexes Eligible for Study:All
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
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 March 2020