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Efficacy and safety of Ustekinumab in the treatment of Chinese patients with Crohn's disease: a multicenter, prospective, real-world clinical study

Efficacy and safety of Ustekinumab in the treatment of Chinese patients with Crohn's disease: a multicenter, prospective, real-world clinical study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000034861
Enrollment
Unknown
Registered
2020-07-22
Start date
2020-07-23
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Crohn's disease

Interventions

case series:N/A

Sponsors

The First Affiliated Hospital of The Fourth Military Medical University (Xijing Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
17 Years to No maximum

Inclusion criteria

Inclusion criteria: 1) Aged >= 17 years; 2) The diagnosis of CD was in accordance with the consensus on diagnosis and treatment of inflammatory bowel disease (2018); 3) Patients with moderate to severe active CD (CDAI >= 220); 4) Ustekinumab was used as induction therapy and / or maintenance therapy.

Exclusion criteria

Exclusion criteria: 1) Contraindications of Ustekinumab; 2) The diagnosis was ulcerative colitis (UC) or atypical colitis (IC) or IBDU; 3) Any type of intestinal resection or other abdominal surgery in the past 3 months, or more than 3 previous intestinal resection history; 4) Severe intestinal stricture, toxic megacolon or fulminant enteritis may require surgery during the visit; 5) History of cancer; 6) The patient was in a state of severe infection (combined with clinical and doctor's judgment).

Design outcomes

Primary

MeasureTime frame
Response rate;Remission rate;IBDQ;

Countries

China

Contacts

Public ContactKaichun Wu

The First Affiliated Hospital of the Fourth Military Medical University

kaicwu@fmmu.edu.cn+86 13709218743

Outcome results

None listed

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