A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
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
- The protocol lists: guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib).
- Who it may be relevant to
- Registry conditions: Inflamatory Bowel Disease. Basic parameters: 14 years — 80 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 →
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Official title
Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD
Overview
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.
Interventions
- Drug guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
Primary outcome measures
- 12-week clinical response and 52-week endoscopic response [Time frame: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).]
Eligibility criteria
Inclusion criteria
- Age 14-80 years with confirmed diagnosis of IBD;
- Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2);
- Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);
- Signed informed consent.
Exclusion criteria
- Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;
- History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia;
- Prior intolerance to JAK inhibitors or IL-23 inhibitors.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliate — Hangzhou
Identifiers
NCT: NCT07487311 · 研2025-1622