Clinical trial NCT03550781: Anti-inflammatory Treatment for Inactive Takayasu Arteritis
Official title: Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Takayasu Arteritis
Anti-Inflammatory Agents
Keywords: Takayasu Arteritis
Anti-Inflammatory Agents
Positron Emission Tomography Computed Tomography
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: Lesion progression
timeFrame: baseline and 12 months
Secondary outcomes:
measure: Lesion progression
timeFrame: baseline, 3 months, 6 months, 9 months
measure: Changes in plasma concentration of tumor necrosis factor
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in plasma concentration of interleukin-2
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in plasma concentration of interleukin-6
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in plasma concentration of interleukin-8
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in plasma concentration of interleukin-10
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in plasma concentration of high-sensitivity C-reactive protein
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
measure: Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph
timeFrame: baseline, 3 months, 6 months, 9 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
name: Xiongjing Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References: