Anti-inflammatory Treatment for Inactive Takayasu Arteritis

NCT ID: NCT03550781

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2021-05-31

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.

Conditions

Takayasu Arteritis; Anti-Inflammatory Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anti-inflammatory treatment group

Prednisone and/or cyclophosphamide

Group Type: EXPERIMENTAL

Prednisone, cyclophosphamide

Intervention Type: DRUG

Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

Control group

No intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prednisone, cyclophosphamide

Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

Intervention Type: DRUG

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)

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese Academy of Medical Sciences, Fuwai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiongjing Jiang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiongjing Jiang, MD

Role: PRINCIPAL_INVESTIGATOR

Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College

Central Contacts

Xiongjing Jiang, MD

Role: CONTACT

jxj103@hotmail.com

86-1088322385

Hui Dong, MD

Role: CONTACT

donghui666@sina.com

+8615810161393

Other Identifiers

2018-992

Identifier Type: -

Identifier Source: org_study_id