Actively Recruiting
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 Takayasu's Arteritis
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-17
124
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.
CONDITIONS
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 Takayasu's Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 2022 ACR/EULAR classification criteria for aortitis
- Men or women aged 18 to 65 years
- Active disease with a National Institutes of Health (NIH) score of 2 or higher
- Female participants must have negative pregnancy tests and no plans to conceive during the trial
- Stable prednisone or equivalent dose not exceeding 0.6 mg/kg/day for at least 4 weeks before enrollment
- Discontinuation of other aortitis medications as required before the study (varying washout periods depending on the medication)
- Evaluation and preventive therapy for latent tuberculosis if T-spot is elevated
- Anti-viral treatment for hepatitis B virus if viral replication is detected prior to enrollment
You will not qualify if you...
- Presence of organ failure
- Receiving hemodialysis or having major surgery (grade III or above) within the last 3 months
- Having other autoimmune diseases
- Severe or progressive organ damage
- Comorbidities likely requiring moderate to high doses of glucocorticoids (prednisone 10 mg/day or equivalent) during the study
- History of malignancy
- Serious acute or chronic infections, including positive hepatitis B surface antigen or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xiufang Kong, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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