ATITA: Anti-inflammatory Treatment for Inactive Takayasu Arteritis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Anti-inflammatory treatment group Prednisone and/or cyclophosphamide |
Drug: Prednisone, cyclophosphamide
Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg
|
| No Intervention: Control group No intervention |
Outcome Measures
Primary Outcome Measures
- Lesion progression [baseline and 12 months]
Progression of previous lesion degree>20% or new lesion
Secondary Outcome Measures
- Lesion progression [baseline, 3 months, 6 months, 9 months]
Progression of previous lesion degree>20% or new lesion
- 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]
- 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 interleukin-10 [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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria;
-
Inactive Takayasu arteritis according to National Institutes of Health criteria;
-
Age ≥ 14 and ≤ 40 years old at the time of informed consent;
-
Patients or guardian agree to participate in the study.
Exclusion Criteria:
-
Active Takayasu arteritis according to National Institutes of Health criteria;
-
Poor compliance, intolerance to or poor response to hormone therapy;
-
Allergy to contrast agent;
-
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)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
- Principal Investigator: Xiongjing Jiang, MD, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2018-992