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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03550781
Other study ID # 2018-992
Secondary ID
Status Not yet recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date June 1, 2018
Est. completion date May 31, 2021

Study information

Verified date June 2018
Source Chinese Academy of Medical Sciences, Fuwai Hospital
Contact Xiongjing Jiang, MD
Phone 86-1088322385
Email jxj103@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date May 31, 2021
Est. primary completion date May 31, 2020
Accepts healthy volunteers No
Gender All
Age group 10 Years to 40 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

Drug:
Prednisone, cyclophosphamide
Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital

Outcome

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