Crohn DiseaseMORENCT05542459
Multi-omics to Predict Responses to Biologics in IBD
An observational study of Crohn Disease and Ulcerative Colitis, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC). Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease, Ulcerative Colitis
- What is being tested?
- Biologics
- How many people
- 1,050 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Nov 2024
- How long will I take part?
- 2 Years
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with inflammatory bowel disease treated with approved biologics
Who may be able to join
- For patients with IBD:
- Patients with IBD treated with approved biologics
- Age 18 or over
- Written informed consent obtained from patient for participation
- For non-IBD healthy volunteers:
- Patients without the diagnosis of IBD or other conditions that, in the opinion of the investigator, not suitable to participate in the study
- Age 18 or over
- Written informed consent obtained from patient for participation
Who cannot join
- Unable to obtain written informed consent
- Patient is, in the opinion of the investigator, not suitable to participate in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Hongsheng Yang, MD, +86-20-38663423, hensonyang@foxmail.com
Xiang Gao, MD
About this study
Official title: Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease
Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).
Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.
In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.
- Conditions
- Crohn Disease, Ulcerative Colitis
- Being tested
- Biologics
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiologicsDrug
Infliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD
| Study group | Role | What they receive |
|---|---|---|
| Non-IBD control group | A control group in which patients are not diagnosed as inflammatory bowel disease. | |
| CD group | A group in which patients are diagnosed as crohn's disease Receives: Drug: Biologics | |
| UC group | A group in which patients are diagnosed as ulcerative colitis Receives: Drug: Biologics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response
The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI <150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis
Measured: At week 14-26
Mucosal healing
Mucosal healing is defined as absence of mucosal ulceration
Measured: At week 42-64
Secondary outcomes (8)
Clinical response rate with steroids or without steroids
Clinical response rate with steroids or without steroids at week 14-26 and week 42-64
Measured: At week 14-26 and week 42-64
Clinical remission rate with steroids or without steroids
Clinical remission rate with steroids or without steroids at week 14-26 and week 42-64
Measured: At week 14-26 and week 42-64
Objective response rate
Objective response was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64
Measured: At week 14-26 and week 42-64
Objective remission rate
Objective remission was defined based on results obtained from at least 1 among endoscopy, bowel ultrasound, and computerized tomography (CT) or magnetic resonance (MR) enteroclysis at week 14-26 and week 42-64
Measured: At week 14-26 and week 42-64
Inflammatory Bowel Disease Questionnaire (IBDQ) score
IBDQ score at baseline, week 14-26 and week 42-64
Measured: At baseline, week 14-26 and week 42-64
36-Item Short Form Health Survey (SF-36) score
SF-36 score at baseline, week 14-26 and week 42-64
Measured: At baseline, week 14-26 and week 42-64
EQ-5D score
EQ-5D score at baseline, week 14-26 and week 42-64
Measured: At baseline, week 14-26 and week 42-64
Incidence of adverse events
Incidence of adverse events through study completion
Measured: Through study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study start1 Jan 2020
- Primary completion1 Nov 2024 (estimated)
- Study completion1 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Prospective
- Enrolment
- 1,050 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Gao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05542459
- Sponsor's protocol ID
- 2022ZSLYEC-136
- Acronym
- MORE
- Status last verified
- Sep 2022
- First submitted
- 10 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li Q, Huang Z, Yang H, Tang J, Zuo T, Yang Q, Huang Z, Guo Q, Li M, Gao X, Chao K. Intestinal mRNA expression profiles associated with mucosal healing in ustekinumab-treated Crohn's disease patients: bioinformatics analysis and prospective cohort validation. J Transl Med. 2024 Jun 26;22(1):595. doi: 10.1186/s12967-024-05427-w.
PubMed 38926732
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-omics to Predict Responses to Biologics in Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT05542459
- Acronym / sponsor ID
- MORE / 2022ZSLYEC-136
- Conditions
- Crohn Disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,050 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 Nov 2024 (estimated)
- First posted
- 15 Sep 2022 (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.
Inflammatory bowel disease (IBD) is a chronic immune-related disease, which mainly affects the digestive tract. There are mainly two forms of the disease, including Crohn's disease (CD) and ulcerative colitis (UC).
Biologics have revolutionized the treatment of inflammatory bowel disease with good efficacy and safety. However, 20-50% of patients may not response to or lose response to biologics. Unfortunately, there has been no factors or measures that may predict the efficacy or safety of biologics.
In this study, a large prospective cohort study is conducted to evaluate the efficacy and safety of biologics (infliximab, adalimumab, vedolizumab, ustekinumab, and other approved biologics) in patients with inflammatory bowel disease in the real clinical practice. Meanwhile, a multi-omics approach involving transcriptomics, microbiome, proteomics, and metabolome, are adopted to explore biomarkers or factors that predict the therapeutic efficacy or safety of biologics. The mechanism underlie the disease will also be explored.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non-IBD control group | – | –A control group in which patients are not diagnosed as inflammatory bowel disease. |
| CD group | – | Drug: BiologicsA group in which patients are diagnosed as crohn's disease |
| UC group | – | Drug: BiologicsA group in which patients are diagnosed as ulcerative colitis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with inflammatory bowel disease treated with approved biologics
Key inclusion criteria (8 listed)
- For patients with IBD:
- For non-IBD healthy volunteers:
Key exclusion criteria (2 listed)
- Unable to obtain written informed consent
- Patient is, in the opinion of the investigator, not suitable to participate in the study
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 |
|---|---|---|
| BiologicsInfliximab, adalimumab, vedolizumab, ustekinumab, and other biologics approved for IBD | Drug | CD group, UC group |
Primary outcome
Clinical response
Time frame: At week 14-26
The reduction of Crohn's Disease Activity Index (CDAI) ≥70 or CDAI <150 for Crohn's disease; a reduction of the Mayo Clinical Score ≥2 for ulcerative colitis
Mucosal healing
Time frame: At week 42-64
Mucosal healing is defined as absence of mucosal ulceration
8 secondary outcomes
Clinical response rate with steroids or without steroids
Time frame: At week 14-26 and week 42-64
Clinical remission rate with steroids or without steroids
Time frame: At week 14-26 and week 42-64
Objective response rate
Time frame: At week 14-26 and week 42-64
Objective remission rate
Time frame: At week 14-26 and week 42-64
Inflammatory Bowel Disease Questionnaire (IBDQ) score
Time frame: At baseline, week 14-26 and week 42-64
36-Item Short Form Health Survey (SF-36) score
Time frame: At baseline, week 14-26 and week 42-64
EQ-5D score
Time frame: At baseline, week 14-26 and week 42-64
Incidence of adverse events
Time frame: Through study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Derived from this study: PubMed 38926732Li Q, Huang Z, Yang H, Tang J, Zuo T, Yang Q, Huang Z, Guo Q, Li M, Gao X, Chao K. Intestinal mRNA expression profiles associated with mucosal healing in ustekinumab-treated Crohn's disease patients: bioinformatics analysis and prospective cohort validation. J Transl Med. 2024 Jun 26;22(1):595. doi: 10.1186/s12967-024-05427-w.
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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.
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 and Ulcerative Colitis, 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 8 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: status not confirmed, as of the sponsor's last update on 15 Sep 2022. 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 Hongsheng Yang, MD (+86-20-38663423, hensonyang@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response (time frame: At week 14-26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05542459, which also lists 1 linked publication.
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 15 Sep 2022.