Anti-inflammatory Treatment for Inactive Takayasu Arteritis

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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