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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03550781 |
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Date of registration:
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05/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Anti-inflammatory Treatment for Inactive Takayasu Arteritis
ATITA |
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Scientific title:
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Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment? |
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Date of first enrolment:
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June 1, 2018 |
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Target sample size:
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40 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03550781 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2/Phase 3
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Contacts
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Name:
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Xiongjing Jiang, MD |
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Address:
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Telephone:
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86-1088322385 |
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Email:
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jxj103@hotmail.com |
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Affiliation:
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Name:
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Xiongjing Jiang, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College |
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Key inclusion & exclusion criteria
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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)
Age minimum:
10 Years
Age maximum:
40 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Anti-Inflammatory Agents
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Takayasu Arteritis
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Intervention(s)
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Drug: Prednisone, cyclophosphamide
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Primary Outcome(s)
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Lesion progression
[Time Frame: baseline and 12 months]
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Secondary Outcome(s)
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Changes in plasma concentration of interleukin-6
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Changes in plasma concentration of interleukin-8
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Lesion progression
[Time Frame: baseline, 3 months, 6 months, 9 months]
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Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Changes in plasma concentration of interleukin-2
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Changes in plasma concentration of high-sensitivity C-reactive protein
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Changes in plasma concentration of tumor necrosis factor
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Changes in plasma concentration of interleukin-10
[Time Frame: baseline, 3 months, 6 months, 9 months and 12 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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