<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02981979</url>
  </required_header>
  <id_info>
    <org_study_id>2016ZSLC-06</org_study_id>
    <nct_id>NCT02981979</nct_id>
  </id_info>
  <brief_title>Takayasu Arteritis Clinical Trial in China</brief_title>
  <acronym>TACTIC</acronym>
  <official_title>Comparison of the Efficacy and Safety of Leflunomide Versus Placebo Combine With the Basic Prednisone Therapy in Patients With Active Phase of Takayasu's Arteritis: a Randomized Controlled Double-blinded Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiang lindi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate the efficacy and Safety of Leflunomide in&#xD;
      Patients With Active Phase of Takayasu's Arteritis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants achieving clinical remission</measure>
    <time_frame>From the date of randomization until the end of induced remission therapy, assessed up to 24 weeks</time_frame>
    <description>Clinical remission is defined as follows:&#xD;
No systemic symptoms such as fever, fatigue and weight loss;&#xD;
without new onset of ischemic symptoms and ischemic signs;&#xD;
Serum Erythrocyte sedimentation rate(ESR）levels in normal range (if not, retest after 1 week, take the lower one into analyse);&#xD;
Subject achieving clinical remission should meet all these criteria above.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to achieve clinical remission</measure>
    <time_frame>From the date of randomization until the date of first documented clinical remission, assessed up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean dose of prednisone in each group at the end of induced remission therapy</measure>
    <time_frame>At the end of induced remission therapy, assessed up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrence rate during leflunomide maintenance therapy</measure>
    <time_frame>From the beginning of maintenance therapy to the end of follow up, assessed up to 32 weeks(from the end of the 24th week till the end of the 56th week)</time_frame>
    <description>Recurrence is determined as follows:Kerr score&gt;= 2 or do not meet two or more than two criteria of the clinical remission standard,and the results need to be reconfirm 28 days later.&#xD;
Kerr score:&#xD;
1) presence of systemic symptoms as fever, fatigue and weight loss (1');&#xD;
2）presence of ischemic symptoms or signs (1');&#xD;
3) abnormal serum ESR levels (1');&#xD;
4) progression or new site of vascular lesions on MRA or CTA compared to baseline(1').</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to recurrence during leflunomide maintenance therapy</measure>
    <time_frame>From the beginning of maintenance therapy (the 25th week) to the date of first documented recurrence, assessed up to 32 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with adverse events related to leflunomide treatments</measure>
    <time_frame>From the date of randomization until the end of this trial, assessed up to 56 weeks</time_frame>
    <description>Adverse events include neutropenia, elevated serum level of liver enzymes(&gt; 2 fold of normal upper limit), reproductive toxicity and infection</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of Doctor General Visual Analogue Scale at the end of 24 weeks and 56 weeks compared to baseline</measure>
    <time_frame>From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of participant self-reports at the end of 24 weeks and 56 weeks compared to baseline</measure>
    <time_frame>From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)</time_frame>
    <description>Participant self-reports include Patients General Visual Analogue Scale, SF-36 quality of life questionnaire, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The changes of biomarkers related to Takayasu's disease at the end of 24 weeks and 56 weeks compared to the baseline, including the whole blood cell RNA transcripts, and gene epigenetics.</measure>
    <time_frame>From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiological changes including Magnetic Resonance Angiography or Computed Tomography Angiography at the end of 24 weeks and 56 weeks compared to the baseline</measure>
    <time_frame>From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Takayasu Arteritis</condition>
  <arm_group>
    <arm_group_label>Leflunomide group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use Leflunomide 20mg qd po. for 24 weeks for induced remission therapy combine with the basic prednisone therapy(start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission. If the subject has not achieve clinical remission,do not change prednisone dose）. Subjects who have achieved clinical remission, with the prednisone dose reduced to 10mg within 20 weeks and maintained to the end of 24 weeks enter the maintenance therapy.The next 32 weeks for maintenance therapy use leflunomide combine with prednisone 10mg per day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Use Placebo for 24 weeks for induced remission therapy(24 weeks) and use leflunomide 20mg qd po. for maintenance therapy in the next 32 weeks. Prednisone is used as basic therapy during the whole trial (start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission. Then maintain 10mg per day until the end of the study). All subjects in control group enter maintenance therapy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leflunomide 10mg Tab</intervention_name>
    <description>20mg per day for leflunomide group during the entire study; 20mg per day for control group during the maintenance therapy (start from the 25th week till the end of the study).</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Leflunomide group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Prednisone Acetate</intervention_name>
    <description>basic therapy（start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission.）</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Leflunomide group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebos</intervention_name>
    <description>used in control group during the induced remission therapy for 24 weeks.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent form;&#xD;
&#xD;
          2. Subjects who met the American College of Rheumatology 1990 classification criteria for&#xD;
             Takayasu arteritis:&#xD;
&#xD;
             2.1 Age of onset ≤40 years; 2.2 Claudication of upper or lower extremities; 2.3&#xD;
             Decreased pulsation of 1 or both brachial arteries; 2.4 Difference of ≥ 10 mmHg in&#xD;
             systolic blood pressure between arms; 2.5 Bruit over subclavian arteries or aorta; 2.6&#xD;
             Angiography * showing a branch of the aorta stenosis or occlusion; Meeting more than 3&#xD;
             of 6 criteria suggests the diagnosis of Takayasu arteritis.&#xD;
&#xD;
             * Angiography in this study was replaced by vascular magnetic resonance&#xD;
             angiography（MRA）or computed tomography angiography（CTA）.&#xD;
&#xD;
          3. Males or females between the ages of 18 and 65 years;&#xD;
&#xD;
          4. All subjects agreed to have no childbearing plan during the clinical trial, and the&#xD;
             results of serum or urine pregnancy test for females must be negative;&#xD;
&#xD;
          5. Evidence of disease in active phase during the past 3 months, meeting at least 2 of&#xD;
             the following criteria:&#xD;
&#xD;
             5.1 There is a new onset of vascular ischemia ,in accordance with at least one of the&#xD;
             following:&#xD;
&#xD;
             5.1.1 newly discovered difference of blood pressure between arms (systolic pulse&#xD;
             pressure difference of at least ≥ 10mmHg);&#xD;
&#xD;
             5.1.2 new onset of decreased pulsation of 1 or both brachial arteries;&#xD;
&#xD;
             5.1.3 other new manifestations of vascular ischemia;&#xD;
&#xD;
             5.2 Inflammatory abnormalities, meeting at least one of the following:&#xD;
&#xD;
             5.2.1 Erythrocyte sedimentation rate（ESR） level higher than the normal upper&#xD;
             limit（others factors like infection are excluded）;&#xD;
&#xD;
             5.2.2 high-sensitivity C-reactive protein（hsCRP）≥ 6mg/L or C-reactive protein（CRP）&gt;&#xD;
             10mg/L;&#xD;
&#xD;
             5.3 Imaging examinations show abnormalities suggesting that disease is in active&#xD;
             phase, meeting at least one of the following: 5.3.1 Vascular wall show enhanced signal&#xD;
             on MRA(active inflammation);&#xD;
&#xD;
             5.3.2 enhanced CTA suggests new vascular lesions;&#xD;
&#xD;
             5.3.3 Color Doppler ultrasonography suggests vascular wall inflammation;&#xD;
&#xD;
             5.3.4 PET/CT suggests elevated SUV value on vascular wall;&#xD;
&#xD;
             5.4 Systemic symptoms that can not be explained by other causes: fever, fatigue or&#xD;
             losing weight.&#xD;
&#xD;
          6. If the patient is taking prednisone or its equivalent before screening, the dose&#xD;
             should not exceed 0.6mg/kg/d and keep stable for at least 4 weeks before the first&#xD;
             dose of the trial treatment;&#xD;
&#xD;
          7. If the patient has previously received medication for Takayasu Arteritis, the&#xD;
             withdrawal time before first dose of the trial treatment should meet:&#xD;
&#xD;
        7.1 Leflunomide: ≥ 6 months. If cholestyramine is used at least for 11 days, the withdrawal&#xD;
        time required ≥ 4 weeks;&#xD;
&#xD;
        7.2 Cyclophosphamide ≥ 8 weeks;&#xD;
&#xD;
        7.3 Azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus,&#xD;
        thalidomide, antimalarial or any other medication for Takayasu arteritis but not&#xD;
        specifically allowed during the trial was not taken when the first dose of trial drugs were&#xD;
        given;&#xD;
&#xD;
        7.4 Biological agents such as rituximab, IL-6 receptor antagonists, tumor necrosis factor&#xD;
        inhibitors, etc.: ≥ 3 months;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Takayasu arteritis which only show lesions of vascular dilatation or aneurysm&#xD;
             formation;&#xD;
&#xD;
          2. Takayasu arteritis patients who have received surgery related to revascularization for&#xD;
             Takayasu arteritis (except percutaneoustransluminalangioplasty) within 3 months; or&#xD;
             received percutaneoustransluminalangioplasty within 1 months;&#xD;
&#xD;
          3. Subjects with organ failure, meeting at least one of the following:&#xD;
&#xD;
             3.1 Cardiac function: New York Heart Association grade 4;&#xD;
&#xD;
             3.2 Glomerular filtration rate ≤ 60ml/min;&#xD;
&#xD;
             3.3 Liver function： Child-pugh grade 2 and worse than grade 2;&#xD;
&#xD;
             3.4 High frequency of amaurosis (flare on 3 consecutive days);&#xD;
&#xD;
             3.5 Acute cerebral infarction or cerebral hemorrhage;&#xD;
&#xD;
             3.6 Blood pressure&gt; 160/100mmHg;&#xD;
&#xD;
          4. Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus&#xD;
             erythematosus, Behcet's disease, etc.) besides Takayasu arteritis;&#xD;
&#xD;
          5. Serious or progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal,&#xD;
             pulmonary, cardiac, neurological, or other coexisting medical conditions that are not&#xD;
             associated with Takayasu's arteries but may result in unacceptable risks;&#xD;
&#xD;
          6. Co-morbidities as asthma that may require the use of medium to high doses of&#xD;
             glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents)&#xD;
             during the study period;&#xD;
&#xD;
          7. subjects with history of malignancy diseases;&#xD;
&#xD;
          8. Subjects with any serious acute or chronic infection;&#xD;
&#xD;
          9. Hepatitis B surface antigen positive or hepatitis B DNA positive;&#xD;
&#xD;
         10. Hepatitis C antibody positive;&#xD;
&#xD;
         11. Subjects with clinical or radiological or laboratory evidence of active tuberculosis;&#xD;
&#xD;
         12. Subjects with abnormal laboratory test results, meeting at least 1 of the following:&#xD;
&#xD;
             12.1 Subjects with serum alanine aminotransferase (ALT) or glutamic-oxalacetic&#xD;
             transaminase（AST）≥1.5 fold of the normal upper limit;&#xD;
&#xD;
             12.2 Blood white blood cell count ≤4×10^9 / L;&#xD;
&#xD;
             12.3 Platelet count ≤100 × 10^9 / L;&#xD;
&#xD;
             12.4 Hemoglobin ≤85g / L;&#xD;
&#xD;
             12.5 Other laboratory test abnormalities that may contribute to unacceptable risks for&#xD;
             participants in this study;&#xD;
&#xD;
         13. Subjects who are allergic to any of the investigational drugs;&#xD;
&#xD;
         14. Use treatments and/or medication that are not allowed in this trial:&#xD;
&#xD;
        14.1 History of leflunomide treatment for at least 3 months but not effective;&#xD;
&#xD;
        14.2 Subjects who had undergone plasmapheresis or lymphocyte replacement or immunosorbent&#xD;
        therapy in the last one year, or those who had planned to receive such treatments;&#xD;
&#xD;
        14.3 Patients who are willing to receive attenuated vaccine during the trial;&#xD;
&#xD;
        14.4 Subjects accepted or planned to have organ transplantation;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lindi Jiang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Zhongshan Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bingjie Wu, Doctor</last_name>
    <phone>+86 135-6422-3680</phone>
    <email>wu.bingjie@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Anzhen Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tian Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The first affiliated hospital of Nanchang University</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rui Wu, Doctor</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xijing Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhenbiao Wu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lindi Jiang, Doctor</last_name>
      <phone>086-13564223680</phone>
      <email>jiang.lindi@zs-hospital.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Bingjie Wu, Doctor</last_name>
      <email>wu.bingjie@zs-hospital.sh.cn</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Renji Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liangjing Lv</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanxi Da Hospital</name>
      <address>
        <city>Taiyuan</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Liyun Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xinjiang Uygur Autonomous Region People's Hospital</name>
      <address>
        <city>Urumqi</city>
        <state>Xinjiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lijun Wu</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>June 25, 2022</last_update_submitted>
  <last_update_submitted_qc>June 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Zhongshan Hospital</investigator_affiliation>
    <investigator_full_name>Jiang lindi</investigator_full_name>
    <investigator_title>Chief of Department of Rheumatology</investigator_title>
  </responsible_party>
  <keyword>Takayasu Arteritis</keyword>
  <keyword>Leflunomide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Takayasu Arteritis</mesh_term>
    <mesh_term>Aortic Arch Syndromes</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prednisone</mesh_term>
    <mesh_term>Leflunomide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02981979
org study id: 2016ZSLC-06
nct id: NCT02981979
lead sponsor: 
has dmc: No
The purpose of this study is to investigate the efficacy and Safety of Leflunomide in
      Patients With Active Phase of Takayasu's Arteritis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of participants achieving clinical remission
time frame: From the date of randomization until the end of induced remission therapy, assessed up to 24 weeks
description: Clinical remission is defined as follows:
No systemic symptoms such as fever, fatigue and weight loss;
without new onset of ischemic symptoms and ischemic signs;
Serum Erythrocyte sedimentation rate(ESR）levels in normal range (if not, retest after 1 week, take the lower one into analyse);
Subject achieving clinical remission should meet all these criteria above.
measure: Time to achieve clinical remission
time frame: From the date of randomization until the date of first documented clinical remission, assessed up to 24 weeks
measure: Mean dose of prednisone in each group at the end of induced remission therapy
time frame: At the end of induced remission therapy, assessed up to 24 weeks
measure: Recurrence rate during leflunomide maintenance therapy
time frame: From the beginning of maintenance therapy to the end of follow up, assessed up to 32 weeks(from the end of the 24th week till the end of the 56th week)
description: Recurrence is determined as follows:Kerr score>= 2 or do not meet two or more than two criteria of the clinical remission standard,and the results need to be reconfirm 28 days later.
Kerr score:
1) presence of systemic symptoms as fever, fatigue and weight loss (1');
2）presence of ischemic symptoms or signs (1');
3) abnormal serum ESR levels (1');
4) progression or new site of vascular lesions on MRA or CTA compared to baseline(1').
measure: Time to recurrence during leflunomide maintenance therapy
time frame: From the beginning of maintenance therapy (the 25th week) to the date of first documented recurrence, assessed up to 32 weeks
measure: Number of participants with adverse events related to leflunomide treatments
time frame: From the date of randomization until the end of this trial, assessed up to 56 weeks
description: Adverse events include neutropenia, elevated serum level of liver enzymes(> 2 fold of normal upper limit), reproductive toxicity and infection
measure: The changes of Doctor General Visual Analogue Scale at the end of 24 weeks and 56 weeks compared to baseline
time frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)
measure: The changes of participant self-reports at the end of 24 weeks and 56 weeks compared to baseline
time frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)
description: Participant self-reports include Patients General Visual Analogue Scale, SF-36 quality of life questionnaire, and the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale
measure: The changes of biomarkers related to Takayasu's disease at the end of 24 weeks and 56 weeks compared to the baseline, including the whole blood cell RNA transcripts, and gene epigenetics.
time frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)
measure: Radiological changes including Magnetic Resonance Angiography or Computed Tomography Angiography at the end of 24 weeks and 56 weeks compared to the baseline
time frame: From the date of randomization until the end of induced remission therapy (24 weeks) and maintenance therapy (56 weeks)
arm group label: Leflunomide group
arm group type: Active Comparator
description: Use Leflunomide 20mg qd po. for 24 weeks for induced remission therapy combine with the basic prednisone therapy(start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission. If the subject has not achieve clinical remission,do not change prednisone dose）. Subjects who have achieved clinical remission, with the prednisone dose reduced to 10mg within 20 weeks and maintained to the end of 24 weeks enter the maintenance therapy.The next 32 weeks for maintenance therapy use leflunomide combine with prednisone 10mg per day.
arm group label: Control Group
arm group type: Placebo Comparator
description: Use Placebo for 24 weeks for induced remission therapy(24 weeks) and use leflunomide 20mg qd po. for maintenance therapy in the next 32 weeks. Prednisone is used as basic therapy during the whole trial (start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission. Then maintain 10mg per day until the end of the study). All subjects in control group enter maintenance therapy.
intervention type: Drug
intervention name: Leflunomide 10mg Tab
description: 20mg per day for leflunomide group during the entire study; 20mg per day for control group during the maintenance therapy (start from the 25th week till the end of the study).
arm group label: Control Group
arm group label: Leflunomide group
intervention type: Drug
intervention name: Prednisone Acetate
description: basic therapy（start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission.）
arm group label: Control Group
arm group label: Leflunomide group
intervention type: Drug
intervention name: Placebos
description: used in control group during the induced remission therapy for 24 weeks.
arm group label: Control Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lindi Jiang, Doctor
role: Principal Investigator
affiliation: Shanghai Zhongshan Hospital
last name: Bingjie Wu, Doctor
phone: +86 135-6422-3680
email: wu.bingjie@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Shanghai Zhongshan Hospital
investigator full name: Jiang lindi
investigator title: Chief of Department of Rheumatology
mesh term: Arteritis
mesh term: Takayasu Arteritis
mesh term: Aortic Arch Syndromes
mesh term: Prednisone
mesh term: Leflunomide