Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06520397
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohns Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Efficacy and Safety of Dual-targeted Therapy With Upadacitinib and Ustekinumab Versus Intensified Ustekinumab Therapy in Crohns Disease Patients With an Insufficient Response to Standard-dose Ustekinumab A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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:
The goal of this clinical trial is to evaluate the efficacy and safety of dual-target therapy Ustekinumab combined with Upadacitinib versus intensified Ustekinumab monotherapy in patients with Crohns disease who have an inadequate response to standard doses of Ustekinumab The main questions it aims to answer are
Is dual-target therapy more effective than intensified Ustekinumab monotherapy in achieving endoscopic remission in Crohns disease patients
Is dual-target therapy as safe as intensified Ustekinumab monotherapy in terms of adverse events
Participants will
Receive either dual-target therapy Ustekinumab combined with Upadacitinib or intensified Ustekinumab monotherapy
Attend regular clinic visits for monitoring and assessments Complete questionnaires about their symptoms and quality of life Undergo routine blood tests and endoscopic evaluations to assess disease activity
Researchers will compare the dual-target therapy group to the intensified Ustekinumab monotherapy group to see if dual-target therapy is more effective in achieving endoscopic remission and is as safe in terms of adverse events
Is dual-target therapy more effective than intensified Ustekinumab monotherapy in achieving endoscopic remission in Crohns disease patients
Is dual-target therapy as safe as intensified Ustekinumab monotherapy in terms of adverse events
Participants will
Receive either dual-target therapy Ustekinumab combined with Upadacitinib or intensified Ustekinumab monotherapy
Attend regular clinic visits for monitoring and assessments Complete questionnaires about their symptoms and quality of life Undergo routine blood tests and endoscopic evaluations to assess disease activity
Researchers will compare the dual-target therapy group to the intensified Ustekinumab monotherapy group to see if dual-target therapy is more effective in achieving endoscopic remission and is as safe in terms of adverse events
Detailed Description:
None
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