Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease
- Registration Number
- NCT05705856
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description intravenous maintenance at early stage Ustekinumab 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. intravenous escalation when poor response Ustekinumab 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.
- Primary Outcome Measures
Name Time Method Percentage of participants with steroid-free clinical remission at Week 24 Week24 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.
- Secondary Outcome Measures
Name Time Method Percentage of participants with endoscopic remission at Week 52 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.
Percentage of participants with normal fecal calprotectin level at Week 52 Week 52 Percentage of participants with normal fecal calprotectin level at 52w (among patients with baseline fecal calprotectin greater than 200ug/g)
Percentage of Participants with Infections and Serious Infections up to 1.5 years Percentage of participants with infections and serious infections will be reported.
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) up to 1.5 years 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.
Percentage of participants with biochemical remission at Week 24 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.
Percentage of Participants continue UST up to 1.5 years Proportion of patients who continue UST during the follow-up will be assessed.
Trial Locations
- Locations (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
🇨🇳Hangzhou, Zhejiang, China