Anti-inflammatory Treatment for Inactive Takayasu Arteritis

• Status: Unknown status
• Trial end date: 2021-05-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
• Treatments: Anti-Inflammatory Agents; Cyclophosphamide; Prednisone

Criteria

Inclusion Criteria:

1. Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;

2. Inactive Takayasu arteritis according to National Institutes of Health criteria;

3. Age ≥ 14 and ≤ 40 years old at the time of informed consent;

4. Patients or guardian agree to participate in the study.

Exclusion Criteria:

1. Active Takayasu arteritis according to National Institutes of Health criteria;

2. Poor compliance, intolerance to or poor response to hormone therapy;

3. Allergy to contrast agent;

4. 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)