Predicting Upadacitinib Effectiveness in Crohn's Disease Patients
Intestinal Ultrasound Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohn's Disease：a Prospective Study
This study is testing if upadacitinib can help people with moderate to severe Crohn's disease feel better by using intestinal ultrasound to track how well the treatment works.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 34 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Third Xiangya Hospital of Central South University Academic / other |
| Drugs / interventions | Upadacitinib, upatinib |
| Locations | 1 site (Hunan, Hunan) |
| Trial ID | NCT06573944 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of upadacitinib, a selective JAK-1 inhibitor, in patients with moderate to severe Crohn's disease using intestinal ultrasound (IUS) as a predictive tool. The study will involve patients aged 18 to 80 who are newly diagnosed or experiencing a relapse of their condition, with treatment proposed within one month after baseline assessments. By utilizing IUS, the study seeks to enhance the monitoring of treatment responses and improve patient outcomes. The findings could provide valuable insights into the efficacy of this novel oral medication for managing Crohn's disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 80 with newly diagnosed or relapsed moderate to severe Crohn's disease who are eligible for upadacitinib therapy.
Not a fit: Patients with contraindications to upadacitinib or those who have undergone extensive colectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective treatment strategies for patients with moderate to severe Crohn's disease.
How similar studies have performed: While there have been successful studies on upadacitinib for Crohn's disease, the specific predictive use of IUS in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years and ≤ 80 years; * Patients with newly diagnosed or relapsed moderate to severe Crohn's disease * Upadacitinib therapy is proposed to be applied within 1 month after baseline endoscopy and intestinal ultrasound,; * No history of abdominal surgery; * Clearly understand, voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: * Contraindications to upadacitinib: allergy, active tuberculosis or other active infections, moderate-to-severe heart failure (NYHA grade III/ IV), demyelinating lesions of the nervous system, live vaccination within the last 3 months, pregnancy and lactation; * Patients with a history of extensive colectomy or recent proposed colectomy, history of colonic mucosal dysplasia; * Hypersensitivity to the components of SonoVue contrast media.
Where this trial is running
Hunan, Hunan
- The Third Xiangya Hospital of Central South University — Hunan, Hunan, China (Recruiting)
Study contacts
- Study coordinator: Li Tian
- Email: f3tianli@outlook.com
- Phone: 0731-13574843423
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.