A multicenter study on the relationship between drug concentration of ustekinumab and treatment efficiency in crohn's disease

A multicenter prospective observational study on the relationship between drug concentration of ustekinumab and treatment efficiency in crohn's disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2400084547

Enrollment

Unknown

Registered

2024-05-20

Start date

2023-03-01

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

Crohn's disease

Interventions

Observation group:None

Eligibility

Sex/Gender

All

Age

18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with moderate-to-severe active CD (CDAI220-450 score and colonoscopy with evidence of active inflammation in at least 1 of 5 ileocolonic segments, SES-CD > 4) who previously did not respond, lost response, or were intolerant to TNF antagonists or conventional therapy. (2) The age is 18-75 years

Exclusion criteria

Exclusion criteria: (1) Patients with stoma or extensive colon resection (2) Receiving total parenteral nutrition or total enteral nutrition (3) Severe organ insufficiency (4) IBD-U (5) Pregnancy and lactation

Design outcomes

Primary

Measure	Time frame
Endoscopic SES-CD score;	—

Secondary

Measure	Time frame
CRP;CDAI;IBDQ;	—

Countries

China

Contacts

Public ContactHongjie Zhang

Jiangsu Province Hospital

hjzhang06@163.com+86 139 5197 5918

Outcome results

None listed

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