Anti-inflammatory Treatment for Inactive Takayasu Arteritis (ATITA)

Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？

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 Overview

• Status: Unknown
• Conditions: Takayasu Arteritis; Anti-Inflammatory Agents
• Intervention / Treatment: Drug: Prednisone, cyclophosphamide

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control group; No intervention
EXPERIMENTAL: Anti-inflammatory treatment group; Prednisone and/or cyclophosphamide	Drug: Prednisone, cyclophosphamide; Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion progression	Progression of previous lesion degree>20% or new lesion	baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion progression	Progression of previous lesion degree>20% or new lesion	baseline, 3 months, 6 months, 9 months
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

Collaborators and Investigators

• Sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): May 31, 2020
• Study Completion (ANTICIPATED): May 31, 2021

Study Registration Dates

• First Submitted: May 5, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 7, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Takayasu Arteritis; Anti-Inflammatory Agents; Positron Emission Tomography Computed Tomography
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Vasculitis; Skin Diseases, Vascular; Aortic Diseases; Arteritis; Takayasu Arteritis; Aortic Arch Syndromes; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Cyclophosphamide; Prednisone
• Other Study ID Numbers: 2018-992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No