Brief Title
Anti-inflammatory Treatment for Inactive Takayasu Arteritis
Official Title
Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory 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.
Study Phase
Phase 2/Phase 3
Study Type
Interventional
Primary Outcome
Lesion progression
Secondary Outcome
Lesion progression
Condition
Takayasu Arteritis
Intervention
Prednisone, cyclophosphamide
Study Arms / Comparison Groups
Anti-inflammatory treatment group
Description: Prednisone and/or cyclophosphamide
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
June 1, 2018
Completion Date
May 31, 2021
Primary Completion Date
May 31, 2020
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)
Gender
All
Ages
10 Years - 40 Years
Accepts Healthy Volunteers
No
Contacts
Xiongjing Jiang, MD, 86-1088322385, [email protected]
Administrative Informations
NCT ID
NCT03550781
Organization ID
2018-992
Responsible Party
Principal Investigator
Study Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
Study Sponsor
Xiongjing Jiang, MD, Principal Investigator, Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
Verification Date
June 2018