IBD (Inflammatory Bowel Disease)NCT07660289
Combined Advanced Targeted Therapy for Inflammatory Bowel Disease
An observational study of IBD (Inflammatory Bowel Disease) and Combined Advanced Targeted Therapy, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
The aim of this retrospective and prospective observational study is to investigate and compare the real-world effectiveness and safety of different dual-target combination therapies in patients with inflammatory bowel disease (IBD). Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- IBD (Inflammatory Bowel Disease), Combined Advanced Targeted Therapy, Combination Therapy
- What is being tested?
- Combination therapy
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2023to 10 Jun 2026
- How long will I take part?
- 56 Weeks
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is a multicenter, retrospective and prospective cohort study conducted at 4 tertiary inflammatory bowel disease (IBD) centers in China from April 2023 to April 2026. A total of 117 patients with IBD were enrolled. All patients received Combined Advanced Targeted Therapy (either two biologic agents, or one biologic agent together with one small molecule agent).
Who may be able to join
- Patients diagnosed with IBD;
- Patients treated with Combined Advanced Targeted Therapy at 4 tertiary IBD centers in China from June 2023 to December 2026.
- Patients with complete and available clinical, endoscopic, and follow-up data；
- Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.
Who cannot join
- 1.Patients with hemodynamic instability; 2.Patients with obvious liver and kidney function injury: bilirubin,aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR < 60ml/min or dialysis patients; 3.Patients allergic to biologic agents or small molecule agents; 4.Patients whose primary disease was gastrointestinal malignancy; 5.Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; 6.Female patients during pregnancy and breastfeeding (including patients with reproductive needs)； 7.Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 8.Patients with missing key data for outcome assessment; 9.Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Combined Advanced Targeted Therapy for Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study
The aim of this retrospective and prospective observational study is to investigate and compare the real-world effectiveness and safety of different dual-target combination therapies in patients with inflammatory bowel disease (IBD).
The key questions to be addressed are:
Read more
In patients with refractory IBD who receive either two biologic agents or one biologic agent plus one small molecule drug, what is the real-world effectiveness and safety of different combination regimens?
The researchers will conduct a retrospective analysis of medical records and electronic health data from patients diagnosed with IBD, and will enroll and document patients receiving combination advanced targeted therapy (CATT) for long-term follow-up. The treatments received by these patients are part of routine first-line clinical care or routine rescue clinical care. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions. Data will be collected during a defined follow-up period to compare the real-world effectiveness and safety profiles of different treatment exposure strategies.
Read the detailed description
This is a retrospective and prospective observational cohort study. All described interventions are part of routine clinical care for patients with inflammatory bowel disease (IBD). Treatment decisions were made by treating clinicians according to the standard of care; the investigator did not prospectively assign, modify, or control any therapeutic interventions. Participants did not receive any intervention specifically for the purpose of this study. The study only involves retrospective analysis of existing medical records to compare real-world outcomes between different treatment exposure patterns.
- Being tested
- Combination therapy
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination therapyDrug
Combination therapy in this study is defined as the concurrent use of either two biologic agents, or one biologic agent together with one small molecule agent.
| Study group | Role | What they receive |
|---|---|---|
| IBD Patients with Combined Advanced Targeted Therapy | Group/Cohort Description: This retrospective and prospective observational cohort includes patients with inflammatory bowel disease (IBD) who received combination therapy (two biologic agents or one biologic agent and one small molecule agent) in routine clinical practice. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records. Receives: Drug: Combination therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical response/remission rate at week 12.
Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;
Measured: week 12
Colectomy-free rate within 90 days
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
Measured: 90 days
Secondary outcomes (2)
Adverse events (AEs) rate
Measured: 90 days
Endoscopic response/remission rate at week 12
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start20 Apr 2023
- Primary completion10 May 2026
- Study completion10 Jun 2026
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 IBD (Inflammatory Bowel Disease)Studies of the same condition, open and under way.
- 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
- 117 participants (actual)
- Target duration
- 56 Weeks
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07660289
- Sponsor's protocol ID
- KY20232425-F-1-2
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Battat R, Chang JT, Loftus EV Jr, Sands BE. IBD Matchmaking: Rational Combination Therapy. Clin Gastroenterol Hepatol. 2025 Feb;23(3):469-479. doi: 10.1016/j.cgh.2024.05.051. Epub 2024 Jul 25.
PubMed 39025253Yang E, Panaccione N, Whitmire N, Dulai PS, Vande Casteele N, Singh S, Boland BS, Collins A, Sandborn WJ, Panaccione R, Battat R. Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease. Aliment Pharmacol Ther. 2020 Jun;51(11):1031-1038. doi: 10.1111/apt.15719. Epub 2020 Apr 24.
PubMed 32329532
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Combined Advanced Targeted Therapy for Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study
- ClinicalTrials.gov ID
- NCT07660289
- Acronym / sponsor ID
- KY20232425-F-1-2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 10 May 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 22 Jun 2026 (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 aim of this retrospective and prospective observational study is to investigate and compare the real-world effectiveness and safety of different dual-target combination therapies in patients with inflammatory bowel disease (IBD).
The key questions to be addressed are:
In patients with refractory IBD who receive either two biologic agents or one biologic agent plus one small molecule drug, what is the real-world effectiveness and safety of different combination regimens?
The researchers will conduct a retrospective analysis of medical records and electronic health data from patients diagnosed with IBD, and will enroll and document patients receiving combination advanced targeted therapy (CATT) for long-term follow-up. The treatments received by these patients are part of routine first-line clinical care or routine rescue clinical care. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions. Data will be collected during a defined follow-up period to compare the real-world effectiveness and safety profiles of different treatment exposure strategies.
Detailed description
This is a retrospective and prospective observational cohort study. All described interventions are part of routine clinical care for patients with inflammatory bowel disease (IBD). Treatment decisions were made by treating clinicians according to the standard of care; the investigator did not prospectively assign, modify, or control any therapeutic interventions. Participants did not receive any intervention specifically for the purpose of this study. The study only involves retrospective analysis of existing medical records to compare real-world outcomes between different treatment exposure patterns.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 56 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD Patients with Combined Advanced Targeted Therapy | – | Drug: Combination therapyGroup/Cohort Description: This retrospective and prospective observational cohort includes patients with inflammatory bowel disease (IBD) who received combination therapy (two biologic agents or one biologic agent and one small molecule agent) in routine clinical practice. All treatment decisions were made by treating clinicians according to the standard of care; the investigator did not assign or modify any therapeutic interventions, and only retrospectively collected and analyzed clinical outcomes from medical records. |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is a multicenter, retrospective and prospective cohort study conducted at 4 tertiary inflammatory bowel disease (IBD) centers in China from April 2023 to April 2026. A total of 117 patients with IBD were enrolled. All patients received Combined Advanced Targeted Therapy (either two biologic agents, or one biologic agent together with one small molecule agent).
Key inclusion criteria (4 listed)
- Patients diagnosed with IBD;
- Patients treated with Combined Advanced Targeted Therapy at 4 tertiary IBD centers in China from June 2023 to December 2026.
- Patients with complete and available clinical, endoscopic, and follow-up data；
- Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.
Key exclusion criteria (1 listed)
- 1.Patients with hemodynamic instability; 2.Patients with obvious liver and kidney function injury: bilirubin,aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR < 60ml/min or dialysis patients; 3.Patients allergic to biologic agents or small molecule agents; 4.Patients whose primary disease was gastrointestinal malignancy; 5.Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.; 6.Female patients during pregnancy and breastfeeding (including patients with reproductive needs)； 7.Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.); 8.Patients with missing key data for outcome assessment; 9.Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.
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 |
|---|---|---|
| Combination therapyCombination therapy in this study is defined as the concurrent use of either two biologic agents, or one biologic agent together with one small molecule agent. | Drug | IBD Patients with Combined Advanced Targeted Therapy |
Primary outcome
clinical response/remission rate at week 12.
Time frame: week 12
Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;
Colectomy-free rate within 90 days
Time frame: 90 days
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
2 secondary outcomes
Adverse events (AEs) rate
Time frame: 90 days
Endoscopic response/remission rate at week 12
Time frame: week 12
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 24 Jun 2026.
- Background: PubMed 39025253Battat R, Chang JT, Loftus EV Jr, Sands BE. IBD Matchmaking: Rational Combination Therapy. Clin Gastroenterol Hepatol. 2025 Feb;23(3):469-479. doi: 10.1016/j.cgh.2024.05.051. Epub 2024 Jul 25.
- Background: PubMed 32329532Yang E, Panaccione N, Whitmire N, Dulai PS, Vande Casteele N, Singh S, Boland BS, Collins A, Sandborn WJ, Panaccione R, Battat R. Efficacy and safety of simultaneous treatment with two biologic medications in refractory Crohn's disease. Aliment Pharmacol Ther. 2020 Jun;51(11):1031-1038. doi: 10.1111/apt.15719. Epub 2020 Apr 24.
- Individual participant dataSharing planned: No
Related trials for IBD (Inflammatory Bowel Disease)
Not yet recruitingObservational study
Longitudinal Registry of Difficult-to-Treat Inflammatory Bowel Disease
Inflammatory Bowel Diseases (IBD), Crohn Disease
Not yet recruitingObservational study
Biophysical Assessments of Acupuncture Points in Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD)
RecruitingObservational study
Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
RecruitingObservational study
Study of Efficacy and Adherence to Subcutaneous vs. Intravenous Vedolizumab in Patients With Inflammatory Bowel Disease Using a Novel Remote MONITORing Intervention
Inflammatory Bowel Disease (IBD), Crohn's Disease
RecruitingObservational study
Family Members at INcreased-risk for Developing Inflammatory Bowel Disease
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC)
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 IBD (Inflammatory Bowel Disease) and Combined Advanced Targeted Therapy, run by Xijing Hospital of Digestive Diseases 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 4 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 24 Jun 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?
clinical response/remission rate at week 12. (time frame: week 12). 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 NCT07660289, 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 24 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.