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A retrospective analysis for the clinical efficacy of continuous intravenous infusion of ustekinumab in patients with isolated perianal Crohn’s disease

A retrospective analysis for the clinical efficacy of continuous intravenous infusion of ustekinumab in patients with isolated perianal Crohn’s disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114257
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

Crohn’s disease

Interventions

Continuous UST intravenous injection treatment group:NA

Sponsors

Second Affiliated Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Age range is 18 to 70 years old. (2) Adopting a continuous UST intravenous infusion treatment plan: the first dose is sufficient UST (6mg/kg) for intravenous induction therapy, followed by intravenous injection of the same dose of UST every 8 weeks for maintenance treatment. (3) Prior to UST treatment, pelvic magnetic resonance imaging (MRI) was performed to evaluate perianal lesions using a 1.5T system consisting of coronal, sagittal, and axial T1, T2 weighted turbo spin echo sequences, as well as axial T2 weighted sequences with fat suppression. (4) No obvious luminal inflammation was found after evaluation by digestive endoscopy (colonoscopy, enteroscopy, gastroscopy), computed tomography enterography (CTE) or magnetic resonance enterography (MRE), intestinal ultrasound (IUS), etc.

Exclusion criteria

Exclusion criteria: (1) Previously treated with infliximab, adalimumab, vedolizumab, or upatinib (small molecule drugs), etc. (2) Take oral corticosteroids, immunosuppressants, or undergo intestinal surgery within 3 months or 24 weeks prior to receiving UST treatment. (3) Significant luminal inflammation was found through digestive endoscopy, CTE or MRE, IUS and other examinations. (4) Combined with cardiovascular and cerebrovascular diseases, severe liver and kidney dysfunction, active tuberculosis, and malignant tumors. (5) Combined with autoimmune diseases such as Sjogren's syndrome, systemic lupus erythematosus, rheumatoid arthritis, Graves' disease, etc.

Design outcomes

Primary

MeasureTime frame
fistula clinical response rate;fistula clinical remission rate;fistula radiologic response rate;

Countries

China

Contacts

Public ContactJiang Yi

Second Affiliated Hospital of Wenzhou Medical University

wzjiangyi@yeah.net+86 577 8567 6609

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026