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RecruitingNot a traditional drug phaseobservationalRules rewrite

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

This study wants 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.

Official registry: https://clinicaltrials.gov/study/NCT07302360 · Xian-Janssen Pharmaceutical Ltd. · enrollment listed as 200

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 200 people at 11 sites. Taking part typically means study visits and measurements plus check-ins.

Official title (unrewritten)

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

Primary outcome (registry wording): Percentage of Participants Achieving Clinical Response at Week 12

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • 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

Public study contact (from the registry)

Study Contact

844-434-4210

Participate-In-This-Study1@its.jnj.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

11 listed

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Inflammatory Bowel Diseases (IBDs), including ulcerative colitis and Crohn's disease (CD), constitute a group of debilitating chronic diseases that profoundly impact patient quality of life and incurs large costs in terms of treatment and lost productivity. Incidence of IBD is rising worldwide, and there is a pressing clinical need for development of new therapies.

NCT06006039 · Official ClinicalTrials.gov record · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

FAQ about this NCT record

Is NCT07302360 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07302360?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07302360?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary