Combined Advanced Targeted Therapy for Inflammatory Bowel Disease

NCT07660289 | Completed

• 1 other identifier: KY20232425-F-1-2
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

IBD (Inflammatory Bowel Disease); Combined Advanced Targeted Therapy; Combination Therapy

Outcome Measures

Primary Outcomes (2)

• 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;

  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

  90 days

Secondary Outcomes (2)

• Adverse events (AEs) rate

  90 days

• Endoscopic response/remission rate at week 12

  week 12

Study Arms (1)

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.

Drug: Combination therapy

Interventions

Combination therapy DRUG

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.

IBD Patients with Combined Advanced Targeted Therapy

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710005, China

Location

Related Publications (2)

• 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.

  PMID: 39025253 BACKGROUND

• Yang 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.

  PMID: 32329532 BACKGROUND

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 56 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 16, 2026
• First Posted: June 22, 2026
• Study Start: April 20, 2023
• Primary Completion: May 10, 2026
• Study Completion: June 10, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)