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
NCT Number: NCT06498089
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Takayasu Arteritis
Interventions: DRUG: Prednisone|DRUG: Methotrexate|DRUG: Cyclophosphamid|DRUG: Tocilizumab|DRUG: Tofacitinib|DRUG: Rituximab
Sponsor: Shanghai Zhongshan Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-28
Completion Date: 2027-06-30
Locations: Zhongshan Hospital, Fudan University, Shanghai, Shanghai, 200032, China

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 Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.

Primary Outcome Measures: Effectiveness rate, Effectiveness is defined if patients meet the following three in criteria ①-④ and criteria ⑤.

* No systemic symptoms such as fever, malaise, or wasting;

  * No new onset of vascular symptoms and signs;

    * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 10mg/day and maintained for at least 4 weeks., 6 months
Secondary Outcome Measures: Effectiveness rate, * No systemic symptoms such as fever, malaise, or wasting;

  * No new onset of vascular symptoms and signs;

    * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 5mg/day and maintained for at least 4 weeks., 12 months|Relapse rate, The relapse is defined as disease re-activation after remission. Disease activity is assessed according to NIH criteria. NIH≥2 is considered active status.

NIH criteria includes:

* Systemic symptoms, such as fever, skeletal and muscular symptoms;

  * Blood sedimentation (erythrocyte sedimentation rate, ESR) \>20mm/H; ③ Characteristics of vascular ischaemia or inflammation: e.g. intermittent claudication, diminished or absent pulse, vascular murmur, vascular pain blood pressure asymmetry; ④Abnormalities of angiography., 12 months|Time to the first relapse, The first time to develop relapse during 12 months' treatment., 12 months|Adverse events, The occurrence of adverse events and the corresponding rate., 12 months|Vascular imaging changes, New vascular lesions, vascular thickness changes, vascular stenosis changes and vascular dilation changes upon MRA or CTA., 12 months|Cytokine changes, Changes of different cytokine profiles, including interleukin levels, chemotactic protein levels, fibrotic marker levels. The spepcific parameters include PTX3, IL6, IFN-g,TNFa, IL8, IL10, IL17, YKL40, CCL22, IL16, CCL2, CCL5, VEGF-A, PDGF-AB, FGF2, MMP1,MMP2, MMP3, MMP9,Leptin, PCSK5, FABP3, GPNMB., 12 months|Improvement of Visual Analog Score for pain, Visual Analog Score for pain score ranges from 0 to 10, higher scores indicate a worse outcome., 12 months|Improvement of 36-Item Short Form Survey, The 36-Item Short Form Survey score ranges from 0 to 800, higher scores indicate a better outcome., 12 months|Improvement of Functional Assessment of Chronic Illness Therapy - Fatigue, The Functional Assessment of Chronic Illness Therapy - Fatigue score ranges from 0 to 52, higher socres indicate a worse outcome., 12 months