Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

NCT ID: NCT05705856

Last Updated: 2023-06-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-15
• Study Completion Date: 2024-06-01

Brief Summary

The primary purpose of this study is to evaluate the efficacy and safety of intravenous administration at regular intervals of Ustekinumab in participants with loss of response to standard regimen or have evidence of high activity clinically, biochemically or endoscopically.

Detailed Description

This study evaluates the efficacy and safety of intravenous administration at regular intervals of Ustekinumab. It consists of escalation treatment period (Week 0 to 52); and safety follow up visit (24 weeks after last dose). Study assessments will include Harvey-Bradshaw index (HBI), Physician Global Assessment Score (PGA), laboratory evaluations, endoscopic evaluation, review of concomitant medications and adverse events (AEs).

Conditions

Crohn Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

intravenous maintenance at early stage

Participants who have evidence of high activity clinically, biochemically or endoscopically : HBI ≥8, inflammatory markers significantly increased (CRP \> 5mg/L, fecal calprotectin\> 200mg/g), SES-CD≥ 7, will get multiple intravenous injections of Ustekinumab maintenance after induction.

Ustekinumab

Intervention Type: DRUG

Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.

intravenous escalation when poor response

Participants who experience a loss of response or poor response to 90 mg Ustekinumab standard therapy will receive Ustekinumab intravenously at regular interval or at shorten interval.

Ustekinumab

Intervention Type: DRUG

Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.

Interventions

Ustekinumab

Patients will receive an intravenous induction (adjusted 6 mg/kg dose) followed by subcutaneous 90 mg every 12 or 8 weeks, and will receive dose escalation when response is not effective enough.

Intervention Type: DRUG

Other Intervention Names

UST; Ustekinumab antibody

Eligibility Criteria

Inclusion Criteria

• Agree to participate in the study
• With active Crohn's disease
• Undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician
• HBI ≥ 5 before Ustekinumab therapy
• Over 18 years of age

Exclusion Criteria

• Who had received Ustekinumab for an indication
• Pregnant or nursing
• L4 type
• History of enterectomy or enterostomy related to disease
• Who used total enteral nutrition for more than 2 weeks due to complications such as obstruction, abscess and perforation after starting Ustekinumab therapy
• Pregnant and lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yan Chen, MD

Role: PRINCIPAL_INVESTIGATOR

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Locations

2nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuting Wang, MD

Role: CONTACT

wangyuting22@126.com

18868102022

Facility Contacts

Yuting Wang, doctor

Role: primary

wangyuting22@126.com

18868102022

Other Identifiers

2023-0004

Identifier Type: -

Identifier Source: org_study_id