Anti-inflammatory Treatment for Inactive Takayasu Arteritis (ATITA)

Chinese Academy of Medical Sciences, Fuwai Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Takayasu Arteritis; Anti-Inflammatory Agents

Treatments: Drug: Prednisone, cyclophosphamide

Study type: Interventional

Funder types: Other

Identifiers

NCT03550781

2018-992

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 10 to 40 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Anti-inflammatory treatment group

Experimental group

Description:

Prednisone and/or cyclophosphamide

Treatment:

Drug: Prednisone, cyclophosphamide

Control group

No Intervention group

Description:

No intervention