Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05705856
• Other study ID #: 2023-0004
• Status: Recruiting
• Start date: February 15, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Yuting Wang, MD
• Phone: 18868102022
• Email: wangyuting22[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 1, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	2nd Affiliated Hospital, School of Medicine, Zhejiang University, China	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of participants with steroid-free clinical remission at Week 24	Percentage of participants with steroid-free clinical remission at Week 24 from the escalation will be assessed. Steroid-free clinical remission (performed only in patients on prednisone or budesonide at time of initiation of UST) was defined as tapering off steroids completely and HBI = 4 points or complete resolution in CD symptoms or severity assessed by PGA.	Week24
Secondary	Percentage of participants with biochemical remission at Week 24	Percentage of participants with biochemical remission at Week 24 from the escalation will be assessed. Biochemical remission was defined as a CRP concentration =5 mg/L and a FCP level of =200 µg/g.	Week 24
Secondary	Percentage of participants with endoscopic remission at Week 52	Percentage of participants with endoscopic remission at Week 52. Endoscopic remission was defined as SES-CD =3 or absence of ulcers or described as the absence of ulceration.	Week 52
Secondary	Percentage of participants with normal fecal calprotectin level at Week 52	Percentage of participants with normal fecal calprotectin level at 52w (among patients with baseline fecal calprotectin greater than 200ug/g)	Week 52
Secondary	Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)	The percentage of participants with at least one adverse event and subcategories of adverse events will be assessed. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.	up to 1.5 years
Secondary	Percentage of Participants with Infections and Serious Infections	Percentage of participants with infections and serious infections will be reported.	up to 1.5 years
Secondary	Percentage of Participants continue UST	Proportion of patients who continue UST during the follow-up will be assessed.	up to 1.5 years