Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573944
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-24
Brief Title:
IUS Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohns Diseasea Prospective Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Intestinal Ultrasound Predicts Upadacitinib Efficacy in Patients With Moderate to Severe Crohns Diseasea Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Crohns disease CD is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood and can present with serious complications such as intestinal obstruction perforation abdominal abscesses and fistulae Currently the main therapeutic drugs for CD include aminosalicylic acid preparations glucocorticoids immunosuppressants and biological agents With the development of medical technology small molecule preparations have begun to be applied to moderate-to-severe Crohns disease
Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor A large real-world study showed that in refractory moderate-to-severe CD upadacitinib showed a clinical response rate of 765 and a clinical remission rate of 706 at 8 weeks of treatment
Intestinal ultrasound IUS is a noninvasive reproducible convenient and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making processThe 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD There are no validated indicators to predict the efficacy of upatinib treatment in patients with moderate-to-severe CD in the currently available studies
Currently there are no national or international studies in which intestinal ultrasound predicts the efficacy of upatinib therapy Therefore we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients with the aim of providing evidence to guide the development of individualized treatment plans
Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor A large real-world study showed that in refractory moderate-to-severe CD upadacitinib showed a clinical response rate of 765 and a clinical remission rate of 706 at 8 weeks of treatment
Intestinal ultrasound IUS is a noninvasive reproducible convenient and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making processThe 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD There are no validated indicators to predict the efficacy of upatinib treatment in patients with moderate-to-severe CD in the currently available studies
Currently there are no national or international studies in which intestinal ultrasound predicts the efficacy of upatinib therapy Therefore we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients with the aim of providing evidence to guide the development of individualized treatment plans
Detailed Description:
Crohns disease CD is a chronic nonspecific inflammatory disease of the intestinal tract whose etiology is not yet fully understood and can present with serious complications such as intestinal obstruction perforation abdominal abscesses and fistulae In recent years the incidence of CD has increased rapidly causing a heavy social and economic burden Currently the main therapeutic drugs for CD include aminosalicylic acid preparations glucocorticoids immunosuppressants and biological agents With the development of medical technology small molecule preparations have begun to be applied to moderate-to-severe Crohns disease providing new treatment options for patients with moderate-to-severe Crohns disease The application of small molecule agents has changed the course of CD But such drugs need to be taken orally for a long period of time and there are risks of secondary infections tumors and loss of responseSo effective prediction of the efficacy of small molecule agents in patients with moderate-to-severe CD is an urgent clinical problem to be solved
Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor A large real-world study showed that in refractory moderate-to-severe CD upadacitinib showed a clinical response rate of 765 and a clinical remission rate of 706 at 8 weeks of treatment Although upadacitinib offers a new treatment option for patients with refractory moderate-to-severe CD there are still some patients who have poor outcomes or treatment ineffectiveness with these drugs Therefore early screening of patients who respond to upadacitinib and prediction of long-term efficacy are important to guide clinical strategies for CD
Intestinal ultrasound IUS is a noninvasive reproducible convenient and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making processThe 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation and in particular normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks There are no validated indicators to predict the efficacy of upadacitinib treatment in patients with moderate-to-severe CD in the currently available studies
Currently there are no national or international studies in which intestinal ultrasound predicts the efficacy of upadacitinib therapy Therefore we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients with the aim of providing evidence to guide the development of individualized treatment plans
Upadacitinib is a novel oral small molecule agent that is a highly selective JAK-1 inhibitor A large real-world study showed that in refractory moderate-to-severe CD upadacitinib showed a clinical response rate of 765 and a clinical remission rate of 706 at 8 weeks of treatment Although upadacitinib offers a new treatment option for patients with refractory moderate-to-severe CD there are still some patients who have poor outcomes or treatment ineffectiveness with these drugs Therefore early screening of patients who respond to upadacitinib and prediction of long-term efficacy are important to guide clinical strategies for CD
Intestinal ultrasound IUS is a noninvasive reproducible convenient and inexpensive test that can greatly increase the frequency of assessing treatment response and speed up the clinical decision-making processThe 2019 ECCO-ESGAR guidelines recommend intestinal ultrasound for disease monitoring in patients with CD Multiple studies have shown that most ultrasound markers normalize within 12 weeks of treatment initiation and in particular normalization of bowel wall thickness is highly correlated with clinical response at 12 weeks There are no validated indicators to predict the efficacy of upadacitinib treatment in patients with moderate-to-severe CD in the currently available studies
Currently there are no national or international studies in which intestinal ultrasound predicts the efficacy of upadacitinib therapy Therefore we propose for the first time that intestinal ultrasound be used as a method to predict the response to upadacitinib in CD patients with the aim of providing evidence to guide the development of individualized treatment plans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None