NCT03550781

Anti-inflammatory Treatment for Inactive Takayasu Arteritis

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital · Academic / Other
• Sex: All
• Age: 10 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Takayasu Arteritis
• Anti-Inflammatory Agents

Interventions

Type	Name	Description
DRUG	Prednisone, cyclophosphamide	Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

Timeline

• Start date: 2018-06-01
• Primary completion: 2020-05-31
• Completion: 2021-05-31
• First posted: 2018-06-08
• Last updated: 2018-06-08