Actively Recruiting
A Randomized, Controlled, Open-label, Multicenter Trial Comparing Precision and Conventional Treatments Based on Clinical-molecular Phenotypes for Active Takayasu's Arteritis
Led by Shanghai Zhongshan Hospital · Updated on 2024-10-17
124
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of a precision treatment plan tailored to clinical-molecular phenotypes compared with a conventional treatment approach in adults with active Takayasu's arteritis. This randomized, controlled, open-label, multicenter study aims to provide clearer insights into managing this condition by assessing outcomes over a 14-month period, including a 6-month induction remission phase and an 8-month maintenance phase. Participants will be randomly assigned to either the precision therapy group or the conventional therapy group. The precision group receives treatments based on their clinical-molecular phenotype: constitutional type patients get glucocorticoids combined with tocilizumab and methotrexate; vascular inflammation type patients receive combinations involving glucocorticoids plus tofacitinib, tocilizumab, adalimumab, and methotrexate depending on specific cytokine elevations. The conventional group receives traditional treatments based on clinical-molecular phenotypes. Prednisone dosing starts based on weight and is gradually tapered over the study. During the study, participants undergo evaluations including effectiveness rates at 6 and 12 months, relapse rates, safety monitoring, hormone dosage tracking, vascular imaging, and cytokine profile changes. Patient-reported outcomes like pain scores, quality of life surveys, and fatigue assessments are also collected. The study includes monitoring for adverse events and continues follow-up through the full 14-month period to assess long-term treatment effects and disease control.
CONDITIONS
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 Takayasu's Arteritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 2022 ACR/EULAR classification criteria for aortitis
- Women or men aged 18 to 65 years
- Have active disease with a National Institutes of Health (NIH) score of 2 or higher
- Females must have negative serum or urine pregnancy tests and no plans for pregnancy during the trial
- If taking prednisone, the dose must be stable and not exceed 0.6 mg/kg/day for at least 4 weeks
- Must discontinue certain medications for specified periods before enrollment (e.g., methotrexate, azathioprine, biologics)
- Patients with elevated T-spot but no active tuberculosis should be evaluated and may receive preventive therapy
- Patients with hepatitis B virus infection must have no viral DNA replication before participation
You will not qualify if you...
- Presence of organ failure
- Undergoing hemodialysis or major surgery within past 3 months
- Presence of other autoimmune diseases
- Severe, progressive organ damage
- Comorbidities requiring moderate to high doses of glucocorticoids during study (prednisone ≥10 mg/day)
- History of malignancy
- Serious acute or chronic infections, including hepatitis B surface antigen positive or active tuberculosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 6 months (0 to 24 weeks)
Participants receive precision or conventional drug treatments based on their clinical-molecular phenotypes during an induction remission period.
Duration - Up to 8 months (24 to 56 weeks)
Participants who achieve clinical remission and meet prednisone dose criteria continue treatment during a maintenance remission period.
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
X
Xiufang Kong, PhD
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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