Combined Advanced Targeted Therapy for Inflammatory Bowel Disease
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:
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.
調査の概要
詳細な説明
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Shaanxi
-
Xi'an、Shaanxi、中国、710005
- Xijing Hosipital of Digestive Disease
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 1.Patients diagnosed with IBD; 2.Patients treated with upadacitinib at 4 tertiary inflammatory bowel disease (IBD) centers in China from June 2023 to December 2026； 3.Patients with complete and available clinical, endoscopic, and follow-up data； 4.Patients for whom the study was approved by the Institutional Research 5.Ethics Committee and conducted in accordance with the Declaration of Helsinki.
Exclusion Criteria:
- 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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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.
|
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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
clinical response/remission rate at week 12.
時間枠：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
時間枠：90 days
|
The proportion of IBD patients who did not undergo colectomy within 90 days after the Combined Advanced Targeted Therapy
|
90 days
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Adverse events (AEs) rate
時間枠：90 days
|
90 days
|
|
Endoscopic response/remission rate at week 12
時間枠：week 12
|
week 12
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Combination therapyの臨床試験
-
Universitätsklinikum Hamburg-EppendorfCytoSorbents, Inc募集
-
Universitätsklinikum Hamburg-Eppendorf完了