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A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

NCT ID: NCT07302360

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-31

Study Completion Date

2028-06-30

Brief Summary

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The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.

Detailed Description

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Conditions

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Colitis, Ulcerative

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Guselkumab: Moderate to Severe Ulcerative Colitis (UC)

Participants with confirmed diagnosis of moderate-to-severe UC treated with guselkumab as per standard clinical practice will be enrolled. No drug will be provided as part of this study. Only data available from standard clinical practice and medical records will be collected and observed.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Has a confirmed diagnosis of moderately to severely active UC, defined as: a) baseline modified Mayo score of 4 to 9; b) screening endoscopy with Mayo endoscopic subscore (MES) greater than or equal to (\>=) 2; c) Mayo rectal bleeding subscore (RBS) \>= 1 at baseline
* Eligible for advanced treatment and initiate guselkumab therapy per participating physician decision in accordance with product package insert
* Have no prior exposure to advanced therapies (bio-naive), such as tumor necrosis factor (TNF)-alpha antagonists, anti-integrin agents, anti-interleukin (IL) agents, sphingosine-1-phosphate receptor modulators, janus kinase (JAK) inhibitors or their corresponding generics and biosimilars, per participating physician assessment
* Participant (and/or their legally-acceptable representative where applicable) must sign an informed consent form (ICF) allowing source data verification in accordance with local requirements

Exclusion Criteria

* Acute severe UC or infectious colitis or other conditions when patients is likely to require a colectomy
* Contraindicated to guselkumab per the label
* Currently enrolled in or plan to participate in any other clinical trials from signing informed consent to the final dose administration of guselkumab
* Participants who will be receiving guselkumab therapy combined with a second advanced therapy
* Participants with a history of colectomy and/or pouch
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xian-Janssen Pharmaceutical Ltd., China Clinical Trial

Role: STUDY_DIRECTOR

Xian-Janssen Pharmaceutical Ltd.

Central Contacts

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Study Contact

Role: CONTACT

Phone: 844-434-4210

Email: [email protected]

Other Identifiers

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CNTO1959UCO4003

Identifier Type: OTHER

Identifier Source: secondary_id

CNTO1959UCO4003

Identifier Type: -

Identifier Source: org_study_id