Xeljanz Special Investigation for Long-term Use in UC Patients

NCT ID: NCT03643211

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2016 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-08

Study Completion Date

2022-11-10

Brief Summary

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Secondary data collection study: safety and effectiveness of Xeljanz in UC patients under Japanese medical practice

Detailed Description

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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.

Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\- None
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Local Country Office

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Matsuoka K, Motoya S, Yamamoto T, Matsuura M, Fujii T, Shinzaki S, Mikami Y, Arai S, Oshima J, Endo Y, Yuasa H, Hoshi M, Sato K, Hisamatsu T. Post-marketing surveillance of tofacitinib in patients with ulcerative colitis in Japan: a final report of safety and effectiveness data. J Gastroenterol. 2025 Aug;60(8):979-989. doi: 10.1007/s00535-025-02249-5. Epub 2025 Apr 21.

Reference Type DERIVED
PMID: 40259041 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A3921248

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Other Identifiers

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A3921248

Identifier Type: -

Identifier Source: org_study_id

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