Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Zhejiang University

Status: Enrolling

Conditions: Crohn Disease

Treatments: Drug: Ustekinumab

Study type: Observational

Funder types: Other

Identifiers

NCT05705856

2023-0004

Details and patient eligibility

About

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.

Full 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).

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

intravenous maintenance at early stage

Description:

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.

Treatment:

Drug: Ustekinumab

intravenous escalation when poor response

Description:

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.

Treatment:

Drug: Ustekinumab