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
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
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)
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
NCT ID
NCT03550781
First Posted
May 5, 2018
Last Updated
June 7, 2018
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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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