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Anti-inflammatory Treatment for Inactive Takayasu Arteritis (ATITA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03550781
Recruitment Status : Unknown
Verified June 2018 by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Takayasu Arteritis Anti-Inflammatory Agents Drug: Prednisone, cyclophosphamide Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Inactive Takayasu Arteritis(NIH Criteria) Need Anti-inflammatory Treatment？
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arms and Interventions
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Arm Intervention/treatment
Experimental: Anti-inflammatory treatment group
Prednisone and/or cyclophosphamide
 Drug: Prednisone, cyclophosphamide
Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg
No Intervention: Control group
No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Lesion progression [ Time Frame: baseline and 12 months ]
    Progression of previous lesion degree>20% or new lesion


Secondary Outcome Measures :
  1. Lesion progression [ Time Frame: baseline, 3 months, 6 months, 9 months ]
    Progression of previous lesion degree>20% or new lesion

  2. Changes in plasma concentration of tumor necrosis factor [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  3. Changes in plasma concentration of interleukin-2 [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  4. Changes in plasma concentration of interleukin-6 [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  5. Changes in plasma concentration of interleukin-8 [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  6. Changes in plasma concentration of interleukin-10 [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  7. Changes in plasma concentration of high-sensitivity C-reactive protein [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]
  8. Changes in 18F-fluorodeoxyglucose uptake by positron emission tomograph [ Time Frame: baseline, 3 months, 6 months, 9 months and 12 months ]

Eligibility Criteria
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Ages Eligible for Study:   10 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03550781


Contacts
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Contact: Xiongjing Jiang, MD 86-1088322385 jxj103@hotmail.com
Contact: Hui Dong, MD +8615810161393 donghui666@sina.com

Sponsors and Collaborators
Chinese Academy of Medical Sciences, Fuwai Hospital
Investigators
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Principal Investigator: Xiongjing Jiang, MD Fuwai Hospital, National Center for Cardiovascular Disease, Chinese Academy of Medical Sciences and Peking Union Medical College
More Information
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Responsible Party: Xiongjing Jiang, Professor, Chinese Academy of Medical Sciences, Fuwai Hospital
ClinicalTrials.gov Identifier: NCT03550781    
Other Study ID Numbers: 2018-992
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiongjing Jiang, Chinese Academy of Medical Sciences, Fuwai Hospital:
Takayasu Arteritis
Anti-Inflammatory Agents
Positron Emission Tomography Computed Tomography
Additional relevant MeSH terms:
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Arteritis
Takayasu Arteritis
Aortic Arch Syndromes
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases
Skin Diseases, Vascular
Skin Diseases
Prednisone
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
 Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal