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

RecruitingOBSERVATIONAL
Enrollment

239

Participants

Timeline

Start Date

August 31, 2024

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2027

Conditions
Crohn DiseaseStricture; BowelIntestinal 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.

Trial Locations (8)

310009

RECRUITING

Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou

Unknown

RECRUITING

Department of Gastroenterology, Seventh Medical Center of PLA Army General Hospital, Beijing

RECRUITING

Department of Gastroenterology, Chongqing Renji Hospital, University of Chinese Academy of Sciences, Chongqing

RECRUITING

Department of Gastroenterology, Sixth Affiliated Hospital, Sun Yat-Sen University, Guangzhou

RECRUITING

Department of Gastroenterology, Huai'an First People's Hospital, Huai'an

RECRUITING

Department of Gastroenterology, Second Affiliated Hospital of Soochow University, Suzhou

RECRUITING

Department of Gastroenterology, Affiliated Hospital of Yangzhou University, Yangzhou

RECRUITING

Department of Gastroenterology, The First Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou

All Listed Sponsors
collaborator

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER

collaborator

Second Affiliated Hospital of Soochow University

OTHER

collaborator

Chongqing Renji Hospital, University of Chinese Academy of Sciences

OTHER_GOV

collaborator

The First Affiliated Hospital of Zhejiang Chinese Medical University

OTHER

collaborator

Seventh Medical Center of PLA Army General Hospital

OTHER

collaborator

First People's Hospital of Hangzhou

OTHER

collaborator

Yangzhou University

OTHER

collaborator

Xian-Janssen Pharmaceutical Ltd.

INDUSTRY

lead

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER