Crohn DiseaseNCT06446219
Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
An observational study of Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn Disease
- Type of treatment
- Pill or oral medicine
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Mar 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population comprises patients aged 18 and older who were hospitalized for Crohn's Disease between January 2020 and March 2024 at our institution or its branches, and who have been received follow-up for no less than 12 weeks prior to March 2024. The study population should also failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). The focus is on adults with a confirmed diagnosis to assess the efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, previously using Upadacitinib/Vedolizumab and absence of clinical data, ensuring a uniform group for valid results.
Who may be able to join
- Patients who were hospitalized in our institution or its branches between January 2020 and March 2024.
- Patients aged 18 years or older.
- Confirmed as moderately-to-severely active Crohn's disease according to Chinese clinical practice guideline on the management of Crohn's disease (2023,Guangzhou).
- Failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab).
- Follow-up time for no less than 12 weeks.
Who cannot join
- Patients who have previously used Upadacitinib and Vedolizumab.
- With insufficient clinical data at baseline, 12 weeks in the Upadacitinib group and 14 weeks in the Vedolizumab group to evaluate the efficacy.
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510655
About this study
Official title: A Retrospective Analysis of the Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory cells. Crohn's Disease significantly affects individuals' quality of life and imposes a high burden on society and healthcare systems. Current treatments don't work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating Crohn's Disease and related conditions, and has been approved by the US FDA for such use.
The investigators' retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab. Investigators aim to enroll patients treated between January 2020 and March 2024, who received follow-up for more than 12 weeks. For patients, families, and healthcare providers, this research could provide a potential new treatment option for Crohn's Disease. Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life. The ultimate goal is to provide more personalized and effective treatment strategies for Crohn's Disease patients in China.
Read the detailed description
This retrospective, multicenter study is designed to compare the efficacy and safety of Upadacitinib and Vedolizumab in second-line treatment for Crohn's Disease, the former is an oral selective enzyme inhibitor, and the latter is a monoclonal antibody targeting integrin α4β7. Crohn's Disease poses a significant impact on the quality of life for individuals and presents a considerable challenge to healthcare systems due to the societal burdens it incurs. While current therapeutic interventions offer relief, these interventions fail to suffice for all patients, with some requiring surgical intervention. Despite the approval of Upadacitinib by the US FDA and its promising application in other nations for Crohn's Disease management, there is a scarcity of data on its effectiveness and safety among Chinese patients. The investigators' research aims to fill this knowledge gap by retrospectively analyzing patient records from multiple hospitals across China. The study targets the adult patients that has received follow-up for more than 12 weeks between January 2020 and March 2024. By assessing the outcomes of these patients, the investigators' objective is to ascertain the potential of Upadacitinib as a viable treatment alternative, which may revolutionize the current Crohn's Disease treatment paradigm in China.The implications of this study are significant for patients, their families, and healthcare providers, as it could herald a new therapeutic avenue for Crohn's Disease management. A clearer understanding of Upadacitinib's role in disease control could enhance patient care by decreasing the necessity for surgical procedures and ameliorating life quality for Crohn's Disease sufferers. The overarching ambition of this research is to pave the way for more individualized and efficacious treatment methodologies for the Crohn's Disease patient populace in China.
- Conditions
- Crohn 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.
| Study group | Role | What they receive |
|---|---|---|
| Upadacitinib(UPA) | Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in Crohn's Disease at a cellular level by selectively inhibiting Janus kinase(JAK)1, a pathway integral to inflammatory cytokine production. This study focuses on its use as main therapy for Chinese patients unresponsive to conventional Crohn's Disease treatments, such as tumor necrosis factor-α inhibitor. Rinvoq is the marketed drugs for clinical use, whose oral dosage is 45 mg per day during the induction period and 15 mg/30 mg per day during maintenance period, and the induction period would last for 8 weeks. | |
| Vedolizumab(VDZ) | Vedolizumab, a monoclonal antibody targeting integrin α4β7, is used to inhibit recruitment of inflammatory cells. This drug is always used as second-line treatment for patients with moderate-to-severe active stage Crohn's Disease who fail to respond to conventional treatments such as tumor necrosis factor-α inhibitor. This study uses Vedolizumab as control group to illustrate the efficacy and safety of Upadacitinib in second-line treatment for Crohn's Disease. Entyvio is the marketed drugs for clinical use, should be given intra-arterially in week 0, 2, 6 and every subsequent 8 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Steroid-Free Clinical Remission
Steroid-Free Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150, achieved without the use of corticosteroids.
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Secondary outcomes (7)
Clinical Remission
Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Clinical Response
Clinical Response in Crohn's Disease is a decrease in Crohn's disease activity index(CDAI) score by 70 points or more from baseline.
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Endoscopic Remission
A simple endoscopic score for Crohn's disease(SES-CD) score of 2 or less indicates endoscopic remission
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Endoscopic Response
Endoscopic Response in Crohn's Disease is a decrease in simple endoscopic score for Crohn's disease(SES-CD) score by 50 percent or more from baseline.
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Mucosal Healing
A simple endoscopic score for Crohn's disease(SES-CD) score of 0 is indicative of mucosal healing
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Radiological Remission
Defined as the complete disappearance or minimization of intestinal inflammation on imaging studies, signifying no visible lesions, normalized wall thickness, absence of strictures or obstructions, and no new areas of disease. Radiographic remission is an important indicator of deep remission in disease treatment goals.
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Radiological Response
Typically defined as a significant reduction in the size of affected areas, decreased wall thickness, and decreased markers of inflammation observed through imaging methods such as MRI or CT scans. A radiographic response indicates a reduction in disease activity but may not represent complete disease remission.
Measured: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Jan 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
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 Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- 172 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446219
- Sponsor's protocol ID
- 2024ZSLYEC-257
- Status last verified
- Jun 2024
- First submitted
- 1 Jun 2024
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Analysis of the Efficacy and Safety Comparison of Upadacitinib and Vedolizumab in Second-line Treatment for Crohn's Disease
- ClinicalTrials.gov ID
- NCT06446219
- Acronym / sponsor ID
- 2024ZSLYEC-257
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 6 Jun 2024 (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.
This study focuses on Upadacitinib, a new oral and small-molecular medication that inhibits specific enzymes involved in inflammation. The goal is to determine efficacy and safety of Upadacitinib for Crohn's Disease patients in China compared with Vedolizumab, which is used to inhibit recruitment of inflammatory cells. Crohn's Disease significantly affects individuals' quality of life and imposes a high burden on society and healthcare systems. Current treatments don't work for everyone, and some patients may need surgery. Upadacitinib has shown promise in other countries for treating Crohn's Disease and related conditions, and has been approved by the US FDA for such use.
The investigators' retrospective and multicenter study looks back at patient records from multiple hospitals to analyze the outcomes of those who have received Upadacitinib and Vedolizumab. Investigators aim to enroll patients treated between January 2020 and March 2024, who received follow-up for more than 12 weeks. For patients, families, and healthcare providers, this research could provide a potential new treatment option for Crohn's Disease. Better efficacy and safety of Upadacitinib than Vedolizumab could lead to better management of the disease, possibly reducing the need for surgery and improving the quality of life. The ultimate goal is to provide more personalized and effective treatment strategies for Crohn's Disease patients in China.
Detailed description
This retrospective, multicenter study is designed to compare the efficacy and safety of Upadacitinib and Vedolizumab in second-line treatment for Crohn's Disease, the former is an oral selective enzyme inhibitor, and the latter is a monoclonal antibody targeting integrin α4β7. Crohn's Disease poses a significant impact on the quality of life for individuals and presents a considerable challenge to healthcare systems due to the societal burdens it incurs. While current therapeutic interventions offer relief, these interventions fail to suffice for all patients, with some requiring surgical intervention. Despite the approval of Upadacitinib by the US FDA and its promising application in other nations for Crohn's Disease management, there is a scarcity of data on its effectiveness and safety among Chinese patients. The investigators' research aims to fill this knowledge gap by retrospectively analyzing patient records from multiple hospitals across China. The study targets the adult patients that has received follow-up for more than 12 weeks between January 2020 and March 2024. By assessing the outcomes of these patients, the investigators' objective is to ascertain the potential of Upadacitinib as a viable treatment alternative, which may revolutionize the current Crohn's Disease treatment paradigm in China.The implications of this study are significant for patients, their families, and healthcare providers, as it could herald a new therapeutic avenue for Crohn's Disease management. A clearer understanding of Upadacitinib's role in disease control could enhance patient care by decreasing the necessity for surgical procedures and ameliorating life quality for Crohn's Disease sufferers. The overarching ambition of this research is to pave the way for more individualized and efficacious treatment methodologies for the Crohn's Disease patient populace in China.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upadacitinib(UPA) | – | –Upadacitinib, a selective Janus kinase (JAK) inhibitor taken orally, is being assessed for its unique capacity to attenuate inflammatory pathways in Crohn's Disease at a cellular level by selectively inhibiting Janus kinase(JAK)1, a pathway integral to inflammatory cytokine production. This study focuses on its use as main therapy for Chinese patients unresponsive to conventional Crohn's Disease treatments, such as tumor necrosis factor-α inhibitor. Rinvoq is the marketed drugs for clinical use, whose oral dosage is 45 mg per day during the induction period and 15 mg/30 mg per day during maintenance period, and the induction period would last for 8 weeks. |
| Vedolizumab(VDZ) | – | –Vedolizumab, a monoclonal antibody targeting integrin α4β7, is used to inhibit recruitment of inflammatory cells. This drug is always used as second-line treatment for patients with moderate-to-severe active stage Crohn's Disease who fail to respond to conventional treatments such as tumor necrosis factor-α inhibitor. This study uses Vedolizumab as control group to illustrate the efficacy and safety of Upadacitinib in second-line treatment for Crohn's Disease. Entyvio is the marketed drugs for clinical use, should be given intra-arterially in week 0, 2, 6 and every subsequent 8 weeks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population comprises patients aged 18 and older who were hospitalized for Crohn's Disease between January 2020 and March 2024 at our institution or its branches, and who have been received follow-up for no less than 12 weeks prior to March 2024. The study population should also failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab). The focus is on adults with a confirmed diagnosis to assess the efficacy in inducing clinical remission and altering disease progression. Exclusion criteria include unclear diagnosis, patients under 18, previously using Upadacitinib/Vedolizumab and absence of clinical data, ensuring a uniform group for valid results.
Key inclusion criteria (5 listed)
- Patients who were hospitalized in our institution or its branches between January 2020 and March 2024.
- Patients aged 18 years or older.
- Confirmed as moderately-to-severely active Crohn's disease according to Chinese clinical practice guideline on the management of Crohn's disease (2023,Guangzhou).
- Failure to respond to or tolerate anti-tumor necrosis factor-α inhibitors (Infliximab, Adalimumab).
- Follow-up time for no less than 12 weeks.
Key exclusion criteria (2 listed)
- Patients who have previously used Upadacitinib and Vedolizumab.
- With insufficient clinical data at baseline, 12 weeks in the Upadacitinib group and 14 weeks in the Vedolizumab group to evaluate the efficacy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Steroid-Free Clinical Remission
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Steroid-Free Clinical Remission in Crohn's Disease is defined as a Crohn's disease activity index(CDAI) score of less than 150, achieved without the use of corticosteroids.
7 secondary outcomes
Clinical Remission
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Clinical Response
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Endoscopic Remission
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Endoscopic Response
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Mucosal Healing
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Radiological Remission
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Radiological Response
Time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Sixth Affiliated Hospital, Sun Yat-sen University 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 2 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: finished, as of the sponsor's last update on 10 Jun 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid-Free Clinical Remission (time frame: Upadacitinib group: assessed at 12 weeks; Vedolizumab group: assessed at 14 weeks;). 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 10 Jun 2024.