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Anti-inflammatory Treatment for Inactive Takayasu Arteritis (ATITA)

Primary Purpose

Takayasu Arteritis, Anti-Inflammatory Agents

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Prednisone, cyclophosphamide
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Takayasu Arteritis focused on measuring Takayasu Arteritis, Anti-Inflammatory Agents, Positron Emission Tomography Computed Tomography

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Anti-inflammatory treatment group

    Control group

    Arm Description

    Prednisone and/or cyclophosphamide

    No intervention

    Outcomes

    Primary Outcome Measures

    Lesion progression
    Progression of previous lesion degree>20% or new lesion

    Secondary Outcome Measures

    Lesion progression
    Progression of previous lesion degree>20% or new lesion
    Changes in plasma concentration of tumor necrosis factor
    Changes in plasma concentration of interleukin-2
    Changes in plasma concentration of interleukin-6
    Changes in plasma concentration of interleukin-8
    Changes in plasma concentration of interleukin-10
    Changes in plasma concentration of high-sensitivity C-reactive protein
    Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph

    Full Information

    First Posted
    May 5, 2018
    Last Updated
    June 7, 2018
    Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03550781
    Brief Title
    Anti-inflammatory Treatment for Inactive Takayasu Arteritis
    Acronym
    ATITA
    Official Title
    Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment?
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 1, 2018 (Anticipated)
    Primary Completion Date
    May 31, 2020 (Anticipated)
    Study Completion Date
    May 31, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese Academy of Medical Sciences, Fuwai Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Takayasu Arteritis, Anti-Inflammatory Agents
    Keywords
    Takayasu Arteritis, Anti-Inflammatory Agents, Positron Emission Tomography Computed Tomography

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anti-inflammatory treatment group
    Arm Type
    Experimental
    Arm Description
    Prednisone and/or cyclophosphamide
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    No intervention
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisone, cyclophosphamide
    Intervention Description
    Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg
    Primary Outcome Measure Information:
    Title
    Lesion progression
    Description
    Progression of previous lesion degree>20% or new lesion
    Time Frame
    baseline and 12 months
    Secondary Outcome Measure Information:
    Title
    Lesion progression
    Description
    Progression of previous lesion degree>20% or new lesion
    Time Frame
    baseline, 3 months, 6 months, 9 months
    Title
    Changes in plasma concentration of tumor necrosis factor
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in plasma concentration of interleukin-2
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in plasma concentration of interleukin-6
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in plasma concentration of interleukin-8
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in plasma concentration of interleukin-10
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in plasma concentration of high-sensitivity C-reactive protein
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months
    Title
    Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph
    Time Frame
    baseline, 3 months, 6 months, 9 months and 12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Takayasu arteritis diagnosed by the American College of Rheumatology 1990 criteria; Inactive Takayasu arteritis according to National Institutes of Health criteria; Age ≥ 14 and ≤ 40 years old at the time of informed consent; Patients or guardian agree to participate in the study. Exclusion Criteria: Active Takayasu arteritis according to National Institutes of Health criteria; Poor compliance, intolerance to or poor response to hormone therapy; Allergy to contrast agent; 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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xiongjing Jiang, MD
    Phone
    86-1088322385
    Email
    jxj103@hotmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hui Dong, MD
    Phone
    +8615810161393
    Email
    donghui666@sina.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Xiongjing Jiang, MD
    Organizational Affiliation
    Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Anti-inflammatory Treatment for Inactive Takayasu Arteritis

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