Anti-inflammatory Treatment for Inactive Takayasu Arteritis

Study Overview
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Brief Summary
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Currently, the traditional disease activity of Takayasu arteritis is mainly based on National Institutes of Health criteria and the inactive cases don't need anti-inflammatory treatment. However, pathologic findings showed that there was still inflammatory activity in the affected vessels, and the follow-up data also found significant lesion progression in some inactive cases. Sixty inactive Takayasu arteritis patients will be recruited to determine whether these individuals are active by screening new inflammatory markers in this study. New inflammatory markers included tumor necrosis factor,interleukin-2,interleukin-6,interleukin-8,interleukin-10,high-sensitivity C-reactive protein, and 18f-FDG positron emission tomograph. According to new inflammatory markers, sixty patients will be divided into two categories: inactive patients (n=20) and active patients (n=40). And then, Forty active patients diagnosed by new inflammatory markers will be randomly assigned to either anti-inflammatory therapy group or control group. The changes of inflammatory activity and lesion progression will be observed during one-year follow up in all 60 patients.

Official Title
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Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？

Conditions
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Takayasu Arteritis, Anti-Inflammatory Agents

Intervention / Treatment
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* Drug: Prednisone, cyclophosphamide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria; Inactive Takayasu arteritis according to National Institutes of Health criteria; Age ≥ 14 and ≤ 40 years old at the time of informed consent; Patients or guardian agree to participate in the study. Exclusion Criteria: Active Takayasu arteritis according to National Institutes of Health criteria; Poor compliance, intolerance to or poor response to hormone therapy; Allergy to contrast agent; Renal insufficiency (serum creatinine >133μmol/L), cardiac insufficiency (NYHA functional class III and IV) or abnormal liver function (Alanine transaminase >1.5 times upper limit of normal)

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-inflammatory treatment group<br>Prednisone and/or cyclophosphamide | Drug: Prednisone, cyclophosphamide<br>* Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg<br>|
| No Intervention: Control group<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion progression | Progression of previous lesion degree>20% or new lesion | baseline and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lesion progression | Progression of previous lesion degree>20% or new lesion | baseline, 3 months, 6 months, 9 months | 
| Changes in plasma concentration of tumor necrosis factor |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in plasma concentration of interleukin-2 |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in plasma concentration of interleukin-6 |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in plasma concentration of interleukin-8 |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in plasma concentration of interleukin-10 |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in plasma concentration of high-sensitivity C-reactive protein |  | baseline, 3 months, 6 months, 9 months and 12 months | 
| Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph |  | baseline, 3 months, 6 months, 9 months and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Takayasu Arteritis, Anti-Inflammatory Agents, Positron Emission Tomography Computed Tomography