Anti-inflammatory Treatment for Inactive Takayasu Arteritis

Phase 2

• Conditions: Anti-Inflammatory Agents; Takayasu Arteritis
• Interventions: Drug: Prednisone, cyclophosphamide

• Registration Number: NCT03550781
• Lead Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-05
• Status Verified: 2018-06
• Study Start: 2018-06-01
• Study First Submitted QC: 2018-06-07
• Last Update Submitted: 2018-06-07
• Study First Posted: 2018-06-08
• Last Update Posted: 2018-06-08
• Primary Completion: 2020-05-31
• Study Completion: 2021-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Anti-inflammatory treatment group	Prednisone, cyclophosphamide	Prednisone and/or cyclophosphamide

Primary Outcome Measures

Name	Time	Method
Lesion progression	baseline and 12 months	Progression of previous lesion degree\>20% or new lesion

Secondary Outcome Measures

Name	Time	Method
Changes in plasma concentration of interleukin-10	baseline, 3 months, 6 months, 9 months and 12 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
Lesion progression	baseline, 3 months, 6 months, 9 months	Progression of previous lesion degree\>20% or new lesion
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 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