Inflammatory Bowel DiseasesNCT04923100
Therapeutic Effect of New Biologics in Crohn's Disease
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2021to 29 Mar 2025
- 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics
Who may be able to join
- Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.
Who cannot join
- loss of follow-up, incomplete clinical data, without confirmed diagnosis
Trial locations and contacts
1 site in 1 country.
China1 site
the Sixth Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 501655
About this study
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
endoscopic remission
Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2
Measured: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Secondary outcomes (3)
clinical remission
Clinical remission was defined as Crohn's disease activity index (CDAI) below 150
Measured: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
clinical response
endoscopic response referred to those with a reduction of SES-CD > 50% baseline
Measured: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
endoscopic response
endoscopic response referred to those with a reduction of SES-CD > 50% baseline
Measured: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start10 Jun 2021
- Primary completion29 Mar 2024
- Study completion29 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04923100
- Sponsor's protocol ID
- 2021ZSLYEC-066
- Status last verified
- Apr 2026
- First submitted
- 7 Jun 2021
- Last updated
- 27 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yao J, Peng X, Zhong Y, Su T, Bihi A, Zhao J, Liu T, Wang W, Hu P, Zhang M, Zhi M. Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease. Front Med (Lausanne). 2023 Jul 24;10:1105981. doi: 10.3389/fmed.2023.1105981. eCollection 2023.
PubMed 37554510Yao JY, Zhang M, Wang W, Peng X, Zhao JZ, Liu T, Li ZW, Sun HT, Hu P, Zhi M. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study. BMC Gastroenterol. 2021 Oct 18;21(1):380. doi: 10.1186/s12876-021-01946-8.
PubMed 34663208
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of New Biologics in Crohn's Disease
- ClinicalTrials.gov ID
- NCT04923100
- Acronym / sponsor ID
- 2021ZSLYEC-066
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 29 Mar 2024 (actual)
- Study completion
- 29 Mar 2025 (actual)
- First posted
- 11 Jun 2021 (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.
New types of biologics have brought advantages in therapy strategies for Crohn's disease. However, clinical data evaluating their efficacy and adverse in China is lacking. We aimed to evaluate the short-term and long-term therapeutic effect as well as drug adverse of Ustekinumab (UST) and Vedolizumab (VED). Besides, we aim to figure out the independent factors predicting the effectiveness of new biologics. Relations between drug exposure (trough concentration and antibody concentration) and therapeutic efficacy are study in-depth by this retrospective observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics
Key inclusion criteria (1 listed)
- Consecutive adult patients with confirmed diagnosis of Crohn's disease and administration of new type biologics.
Key exclusion criteria (1 listed)
- loss of follow-up, incomplete clinical data, without confirmed diagnosis
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
endoscopic remission
Time frame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
Endoscopic remission referred to those with simple endoscopic score for Crohn's disease (SES-CD)≤2
3 secondary outcomes
clinical remission
Time frame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
clinical response
Time frame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
endoscopic response
Time frame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)
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 27 Apr 2026.
- Derived from this study: PubMed 37554510Yao J, Peng X, Zhong Y, Su T, Bihi A, Zhao J, Liu T, Wang W, Hu P, Zhang M, Zhi M. Extra intravenous Ustekinumab reinduction is an effective optimization strategy for patients with refractory Crohn's disease. Front Med (Lausanne). 2023 Jul 24;10:1105981. doi: 10.3389/fmed.2023.1105981. eCollection 2023.
- Derived from this study: PubMed 34663208Yao JY, Zhang M, Wang W, Peng X, Zhao JZ, Liu T, Li ZW, Sun HT, Hu P, Zhi M. Ustekinumab trough concentration affects clinical and endoscopic outcomes in patients with refractory Crohn's disease: a Chinese real-world study. BMC Gastroenterol. 2021 Oct 18;21(1):380. doi: 10.1186/s12876-021-01946-8.
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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.
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 Inflammatory Bowel Diseases and 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 1 inclusion and 1 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 27 Apr 2026. 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?
endoscopic remission (time frame: short-time efficacy (16-20 weeks or 24 weeks) and long-term efficacy (52~54weeks)). 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 NCT04923100, which also lists 2 linked publications.
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 27 Apr 2026.