Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07600255

Enrollment

156

Registered

2026-05-20

Start date

2021-01-01

Completion date

2026-01-20

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's Diseases

Keywords

Crohn's Disease, Ustekinumab, individualized therapy, deep remission

Brief summary

In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks

Exclusion criteria

1. UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs 2. complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors 3. combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases 4. pregnancy or lactation 5. Clinical data missing \> 30%

Design outcomes

Primary

Measure	Time frame	Description
deep remission rate at 44 week	at 44 week	At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated.

Countries

China

Outcome results