Anti-inflammatory Treatment for Inactive Takayasu Arteritis

Takayasu Arteritis Clinical Trial

— ATITA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03550781
• Other study ID #: 2018-992
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• 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
• 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)

Related Conditions & MeSH terms

• Anti-Inflammatory Agents
• Arteritis
• Takayasu Arteritis

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