This Study is to Describe and Evaluate Patients in Finland Treated With Tofacitinib for the Treatment of Ulcerative Colitis Using Real World Data.

NCT ID: NCT05082428

Last Updated: 2024-09-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

252 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-30

Study Completion Date

2022-11-01

Brief Summary

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The aim of this study is to describe and evaluate clinical outcomes, treatment lines, and to identify the key characteristics of the patients treated with tofacitinib.

Detailed Description

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Conditions

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Ulcerative Colitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients treated with Tofacitinib

Patients treated with tofacitinib for ulcerative colitis in Finland.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Xeljanz (tofacitinib) usage for ulcerative colitis
* Diagnosis of ulcerative colitis (ICD-10: K51.0, K51.1, K51.2, K51.3, K51.5, K51.8, K51.9) between January 2010 and December 2021 (incident or prevalent).

Exclusion Criteria

* Age \< 18 years at the start of tofacitinib use
* Use of tofacitinib before reimbursement (1.3.2019)
* \< 8 weeks of treatment with tofacitinib at the start of data mining
* History of panproctocolectomy, IPAA or ileostomy.
Minimum Eligible Age

18 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

Helsinki, , Finland

Site Status

Countries

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Finland

References

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Molander P, Kosunen M, Eronen H, Tillonen J, Karajamaki A, Heikkinen M, Punkkinen J, Mattila R, Toppila I, Holsa O, Kalpala K, Henrohn D, Af Bjorkesten CG. Tofacitinib real-world experience in ulcerative colitis in Finland (FinTofUC): a retrospective non-interventional multicenter patient chart data study. Scand J Gastroenterol. 2024 Apr;59(4):425-432. doi: 10.1080/00365521.2023.2298361. Epub 2023 Dec 29.

Reference Type DERIVED
PMID: 38156792 (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=A3921390

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Other Identifiers

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FinTofUC

Identifier Type: OTHER

Identifier Source: secondary_id

A3921390

Identifier Type: -

Identifier Source: org_study_id

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