Clinical trial NCT05705856: Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease
Official title: Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Keywords: ustekinumab
dose escalation
Crohn's disease
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-01-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing Ustekinumab dose intensification with at least two or more intravenous infusions at the discretion of the treating physician instead of a scheduled SC dose at the discretion of the treating physician.

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).

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

Primary outcomes:
measure: Percentage of participants with steroid-free clinical remission at Week 24
timeFrame: Week24
Secondary outcomes:
measure: Percentage of participants with biochemical remission at Week 24
timeFrame: Week 24
measure: Percentage of participants with endoscopic remission at Week 52
timeFrame: Week 52
measure: Percentage of participants with normal fecal calprotectin level at Week 52
timeFrame: Week 52
measure: Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: up to 1.5 years
measure: Percentage of Participants with Infections and Serious Infections
timeFrame: up to 1.5 years
measure: Percentage of Participants continue UST
timeFrame: up to 1.5 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
state: Zhejiang
Study officials:
affiliation: 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
name: Yan Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: