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NCT06165029
IUS Combined With VAT Predicts Anti-TNF-α Efficacy in Patients With IBD: a Prospective Study
trial in Inflammatory Bowel Diseases in 50 participants. Currently enrolling.
31 December 2024
Quick facts
| Lead sponsor | The Third Xiangya Hospital of Central South University |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 22 November 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 30 March 2025 |
| Sites | 1 location across China |
Conditions studied
- Inflammatory Bowel Diseases — all drugs for Inflammatory Bowel Diseases →
- Intestinal Ultrasound — all drugs for Intestinal Ultrasound →
- Visceral Adipose Tissue — all drugs for Visceral Adipose Tissue →
- TNF-α — all drugs for TNF-α →
Sponsor
The Third Xiangya Hospital of Central South University
Who can join
Adults 18 to 80, any sex, with Inflammatory Bowel Diseases or Intestinal Ultrasound. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Inflammatory Bowel Disease (IBD) is a chronic recurrent nonspecific inflammatory disease of the intestinal tract that can involve multiple organs and systems, mainly including Crohn's disease (CD) and ulcerative colitis (UC). Recurrent disease episodes lead to high rates of disability and unemployment, resulting in a heavy social and economic burden. Currently, the main therapeutic agents for IBD include aminosalicylic acid preparations, glucocorticoids, immunosuppressive agents, and biologic agents, e.g. tumor necrosis factor-a (TNF-a) inhibitors, ustekinumab, etc., with TNF-a inhibitors being the most commonly used in IBD. The latest guidelines and expert consensus on the diagnosis and management of IBD clearly recommend the use of anti-TNF-a agents. However, not all patients are satisfied with the efficacy of anti-TNF-a agents, and studies have shown that up to 33.7% of responders to induction therapy experience secondary loss of response within a year of starting treatment. Patients remain at risk of poor efficacy or treatment failure with these drugs. Therefore, effective prediction of drug efficacy in patients with IBD is an urgent clinical problem, and the discovery of highly sensitive and specific assays that can identify patients most likely to benefit from treatment as well as those most likely to experience a loss of response is important for guiding clinical therapeutic strategies. Currently, there are no relevant studies at home or abroad on the combination of intestinal ultrasound (IUS) with visceral adipose tissue (VAT) to predict the response to anti-TNF-a therapy in IBD patients. Therefore, the investigators propose for the first time that IUS combined with VAT is used as a method to predict the efficacy of anti-TNF-a therapy in IBD patients and to further guide the development of individualized treatment plans.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Other The Third Xiangya Hospital of Central South University trials
Trials by the same sponsor.
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- NCT07034664 — IUS Predicts Guselkumab Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06165029 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by The Third Xiangya Hospital of Central South University
- Last refreshed: 27 August 2024
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