Crohn DiseaseNCT05705856
Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease
An observational study of Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Ustekinumab
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2023to 1 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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 cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang
Yuting Wang, doctor, 18868102022, wangyuting22@126.com
About this study
Official title: Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study
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.
Read the 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
- Being tested
- Ustekinumab
- Keywords
- ustekinumab, dose escalation, Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UstekinumabDrug
Also called UST, Ustekinumab antibody
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ustekinumab | |
| 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. Receives: Drug: Ustekinumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week24
Secondary outcomes (6)
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.
Measured: Week 24
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.
Measured: Week 52
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)
Measured: Week 52
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.
Measured: up to 1.5 years
Percentage of Participants with Infections and Serious Infections
Percentage of participants with infections and serious infections will be reported.
Measured: up to 1.5 years
Percentage of Participants continue UST
Proportion of patients who continue UST during the follow-up will be assessed.
Measured: up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start15 Feb 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Chen, MD, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705856
- Sponsor's protocol ID
- 2023-0004
- Status last verified
- Jan 2023
- First submitted
- 15 Jan 2023
- Last updated
- 13 Jun 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Ustekinumab Intensification in Crohn's Disease: a Retrospective Observational Study
- ClinicalTrials.gov ID
- NCT05705856
- Acronym / sponsor ID
- 2023-0004
- Conditions
- Crohn Disease
- Keywords
- ustekinumab, dose escalation, Crohn's disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 31 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous maintenance at early stage | – | Drug: UstekinumabParticipants 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 | – | Drug: UstekinumabParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UstekinumabAlso: UST, Ustekinumab antibodyPatients 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. | Drug | intravenous escalation when poor response, intravenous maintenance at early stage |
Primary outcome
Percentage of participants with steroid-free clinical remission at Week 24
Time frame: 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.
6 secondary outcomes
Percentage of participants with biochemical remission at Week 24
Time frame: Week 24
Percentage of participants with endoscopic remission at Week 52
Time frame: Week 52
Percentage of participants with normal fecal calprotectin level at Week 52
Time frame: Week 52
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: up to 1.5 years
Percentage of Participants with Infections and Serious Infections
Time frame: up to 1.5 years
Percentage of Participants continue UST
Time frame: up to 1.5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Chen, MD principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yuting Wang, MD (18868102022, wangyuting22@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with steroid-free clinical remission at Week 24 (time frame: Week24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2023.