Ignite Creation Date:
2024-07-17 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498089
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-06-29
Brief Title:
A Randomized Controlled Open-label Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasus Arteritis
Sponsor:
Shanghai Zhongshan Hospital
Organization:
Shanghai Zhongshan Hospital
Study Overview
Official Title:
A Randomized Controlled Open-label Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasus Arteritis
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasus arteritis based on a randomized controlled open-label multicenter study
Detailed Description:
1 This study is a randomised controlled open-label evaluator-blinded multicentre clinical trial with a 14-month 56-week study period a 6-month 0-24 weeks induction remission period and an 8-month 24-56 weeks maintenance remission period
2 Subjects with aortitis who meet the entry criteria will be randomised and divided 11 into the precision therapy group and the conventional therapy group The precision therapy group will be stratified according to the clinical-molecular phenotypes and at the end of 6 months if subjects achieve clinical remission and the amount of GCs is reduced to 75 mgday for 4 weeks they will enter into the maintenance period and continue with the original regimen if they do not meet this they will be withdrawn from the study
3 The study adopts a superiority design the primary study objective is to assess the efficacy of the two groups at the end of six months and the secondary study objectives are to assess the efficiency of the two groups at the end of 12 months relapse rate safety cumulative hormone dose vascular imaging changes changes in cytokine profiles etc
4 According to their new-onset symptoms at baseline or within past three months the patients were divided into two clinical phenotypes â‘ constitutional type patients with constitutional symptoms such as fever fatigue weakness and weight loss without any symptoms of organ ischemia and at least 4 of the following indicators were above normal upper limits ESR CRP C3 PLT IL-6 C4 IgG â‘¡vascular inflammation type patients with vascular-associated symptoms such as carotidynia angina dizziness and limb claudication regardless of the constitutional symptoms or ischemic symptoms
2 Subjects with aortitis who meet the entry criteria will be randomised and divided 11 into the precision therapy group and the conventional therapy group The precision therapy group will be stratified according to the clinical-molecular phenotypes and at the end of 6 months if subjects achieve clinical remission and the amount of GCs is reduced to 75 mgday for 4 weeks they will enter into the maintenance period and continue with the original regimen if they do not meet this they will be withdrawn from the study
3 The study adopts a superiority design the primary study objective is to assess the efficacy of the two groups at the end of six months and the secondary study objectives are to assess the efficiency of the two groups at the end of 12 months relapse rate safety cumulative hormone dose vascular imaging changes changes in cytokine profiles etc
4 According to their new-onset symptoms at baseline or within past three months the patients were divided into two clinical phenotypes â‘ constitutional type patients with constitutional symptoms such as fever fatigue weakness and weight loss without any symptoms of organ ischemia and at least 4 of the following indicators were above normal upper limits ESR CRP C3 PLT IL-6 C4 IgG â‘¡vascular inflammation type patients with vascular-associated symptoms such as carotidynia angina dizziness and limb claudication regardless of the constitutional symptoms or ischemic symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None