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Recruiting NCT07302360

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

— Observational Colitis, Ulcerative

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Colitis, Ulcerative. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Guselkumab Real-world Effectiveness Among Bio-NaÏve Patients With Moderate-to-severe Ulcerative Colitis in China: A Multicenter, Non-interventional, Prospective Study

Overview

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.

Primary outcome measures

  • Percentage of Participants Achieving Clinical Response at Week 12 [Time frame: At Week 12]
Secondary outcome measures (12)
  • Percentage of Participants Achieving Clinical Response at Week 24 and Week 48 [Time frame: At Week 24 and Week 48]
  • Percentage of Participants Achieving Symptomatic Response at Week 2 [Time frame: At Week 2]
  • Mean Change from Baseline in Stool Frequency Subscore (SFS) Over Week 2 [Time frame: From Baseline to Week 2]
  • Mean Change from Baseline in RBS Over Week 2 [Time frame: From Baseline to Week 2]
  • Percentage of Participants Achieving Clinical Remission at Week 12, Week 24 and Week 48 [Time frame: At Week 12, Week 24 and Week 48]
  • Percentage of Participants Achieving Symptomatic Remission at Week 2 [Time frame: At Week 2]
  • Percentage of Participants Achieving Steroid-Free Remission at Week 12, 24 and 48 [Time frame: At Weeks 12, 24 and 48]
  • Percentage of Participants Achieving Sustained Remission at Week 24 and Week 48 [Time frame: At Week 24 and Week 48]
  • Percentage of Participants with Endoscopic Improvement (Healing) at Week 24 and Week 48 [Time frame: At Week 24 and Week 48]
  • Percentage of Participants Achieving Endoscopic Remission (Normalization) at Week 24 and Week 48 [Time frame: At Week 24 and Week 48]
  • Percentage of Participants Discontinuing from Treatment [Time frame: Up to Week 48]
  • Percentage of Participants Switching from Treatment [Time frame: Up to Week 48]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 10 centers
  • Peking Union Medical College Hospital — Beijing
  • Peking University People's Hospital — Beijing
  • Changzhou No 2 Peoples Hospital — Changzhou
  • The First Affiliated Hospital Sun Yat-Sen University — Guangzhou
  • The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou
  • The Second Affiliated Hospital of Zhejiang University — Hangzhou
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou
  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School — Nanjing
  • … and 2 more centers

Identifiers

NCT: NCT07302360 · CNTO1959UCO4003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗