Xijing Hosipital of Digestive Disease
Xi'an, Shaanxi, 710005, China
NCT Number: NCT07660289
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.
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All sexes
Observational
Xi'an, Shaanxi, 710005, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: week 12
Clinical remission is defined as a Mayo score ≤ 2 with no subscore > 1 and a rectal bleeding subscore of 0;
Time frame: 90 days
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
Time frame: 90 days
Time frame: week 12
Xijing Hospital of Digestive Diseases
Other
Efficacy and Safety of Combined Advanced Targeted Therapy for Inflammatory Bowel Disease: A Prospective, Multicenter, Real-World Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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