Efficacy of Ustekinumab Therapy in Patients With Symptomatic Stricturing Crohn's Disease

Summary

This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Conditions

• Crohn Disease
• Stricture; Bowel
• Intestinal Stricture

Interventions

DRUG

Ustekinumab

The initial intravenous (IV) infusion with ustekinumab at baseline was weight-adjusted (260 mg ≤55 kg, 390 mg between 55 and 85 kg, 520 mg ≥85 kg). According to the label, the first subcutaneous (SC) 90 mg induction dose was administered at week 8 followed by a maintenance dose of 90 mg SC every 8 or 12 weeks, at the discretion of the physician. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University

  collaborator OTHER

• Second Affiliated Hospital of Soochow University

  collaborator OTHER

• Chongqing Renji Hospital, University of Chinese Academy of Sciences

  collaborator OTHER_GOV

• The First Affiliated Hospital of Zhejiang Chinese Medical University

  collaborator OTHER

• Seventh Medical Center of PLA Army General Hospital

  collaborator OTHER

• First People's Hospital of Hangzhou

  collaborator OTHER

• Yangzhou University

  collaborator OTHER

• Xian-Janssen Pharmaceutical Ltd.

  collaborator INDUSTRY

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Yan Chen, MD. · Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine

• Jingwen Liu, MD. · Center of IBD, the Second Affiliated Hospital, Zhejiang University School of Medicine

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-01

Primary Completion

2027-08-01

Completion

2028-08-01

FDA Drug

Yes

Countries

• China

Study Locations