Takayasu Arteritis Clinical Trial in China

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Brief Title

Takayasu Arteritis Clinical Trial in China

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

Brief Summary

      The purpose of this study is to investigate the efficacy and Safety of Leflunomide in
      Patients With Active Phase of Takayasu's Arteritis
    



Study Type

Interventional


Primary Outcome

Number of participants achieving clinical remission

Secondary Outcome

 Time to achieve clinical remission

Condition

Takayasu Arteritis

Intervention

Leflunomide 10mg Tab

Study Arms / Comparison Groups

 Leflunomide group
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

116

Start Date

December 2016

Completion Date

June 2020

Primary Completion Date

December 2019

Eligibility Criteria

        Inclusion Criteria:

          1. Signed informed consent form;

          2. Subjects who met the American College of Rheumatology 1990 classification criteria for
             Takayasu arteritis:

             2.1 Age of onset ≤40 years; 2.2 Claudication of upper or lower extremities; 2.3
             Decreased pulsation of 1 or both brachial arteries; 2.4 Difference of ≥ 10 mmHg in
             systolic blood pressure between arms; 2.5 Bruit over subclavian arteries or aorta; 2.6
             Angiography * showing a branch of the aorta stenosis or occlusion; Meeting more than 3
             of 6 criteria suggests the diagnosis of Takayasu arteritis.

             * Angiography in this study was replaced by vascular magnetic resonance
             angiography(MRA)or computed tomography angiography(CTA).

          3. Males or females between the ages of 18 and 65 years;

          4. All subjects agreed to have no childbearing plan during the clinical trial, and the
             results of serum or urine pregnancy test for females must be negative;

          5. Evidence of disease in active phase during the past 3 months, meeting at least 2 of
             the following criteria:

             5.1 There is a new onset of vascular ischemia ,in accordance with at least one of the
             following:

             5.1.1 newly discovered difference of blood pressure between arms (systolic pulse
             pressure difference of at least ≥ 10mmHg);

             5.1.2 new onset of decreased pulsation of 1 or both brachial arteries;

             5.1.3 other new manifestations of vascular ischemia;

             5.2 Inflammatory abnormalities, meeting at least one of the following:

             5.2.1 Erythrocyte sedimentation rate(ESR) level higher than the normal upper
             limit(others factors like infection are excluded);

             5.2.2 high-sensitivity C-reactive protein(hsCRP)≥ 6mg/L or C-reactive protein(CRP)>
             10mg/L;

             5.3 Imaging examinations show abnormalities suggesting that disease is in active
             phase, meeting at least one of the following: 5.3.1 Vascular wall show enhanced signal
             on MRA(active inflammation);

             5.3.2 enhanced CTA suggests new vascular lesions;

             5.3.3 Color Doppler ultrasonography suggests vascular wall inflammation;

             5.3.4 PET/CT suggests elevated SUV value on vascular wall;

             5.4 Systemic symptoms that can not be explained by other causes: fever, fatigue or
             losing weight.

          6. If the patient is taking prednisone or its equivalent before screening, the dose
             should not exceed 0.6mg/kg/d and keep stable for at least 4 weeks before the first
             dose of the trial treatment;

          7. If the patient has previously received medication for Takayasu Arteritis, the
             withdrawal time before first dose of the trial treatment should meet:

        7.1 Leflunomide: ≥ 6 months. If cholestyramine is used at least for 11 days, the withdrawal
        time required ≥ 4 weeks;

        7.2 Cyclophosphamide ≥ 8 weeks;

        7.3 Azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus,
        thalidomide, antimalarial or any other medication for Takayasu arteritis but not
        specifically allowed during the trial was not taken when the first dose of trial drugs were
        given;

        7.4 Biological agents such as rituximab, IL-6 receptor antagonists, tumor necrosis factor
        inhibitors, etc.: ≥ 3 months;

        Exclusion Criteria:

          1. Takayasu arteritis which only show lesions of vascular dilatation or aneurysm
             formation;

          2. Takayasu arteritis patients who have received surgery related to revascularization for
             Takayasu arteritis (except percutaneoustransluminalangioplasty) within 3 months; or
             received percutaneoustransluminalangioplasty within 1 months;

          3. Subjects with organ failure, meeting at least one of the following:

             3.1 Cardiac function: New York Heart Association grade 4;

             3.2 Glomerular filtration rate ≤ 60ml/min;

             3.3 Liver function: Child-pugh grade 2 and worse than grade 2;

             3.4 High frequency of amaurosis (flare on 3 consecutive days);

             3.5 Acute cerebral infarction or cerebral hemorrhage;

             3.6 Blood pressure> 160/100mmHg;

          4. Suffer from other autoimmune diseases (eg, ANCA-associated vasculitis, systemic lupus
             erythematosus, Behcet's disease, etc.) besides Takayasu arteritis;

          5. Serious or progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal,
             pulmonary, cardiac, neurological, or other coexisting medical conditions that are not
             associated with Takayasu's arteries but may result in unacceptable risks;

          6. Co-morbidities as asthma that may require the use of medium to high doses of
             glucocorticoids (prednisone ≥ 10 mg/day or equivalent doses of prednisone equivalents)
             during the study period;

          7. subjects with history of malignancy diseases;

          8. Subjects with any serious acute or chronic infection;

          9. Hepatitis B surface antigen positive or hepatitis B DNA positive;

         10. Hepatitis C antibody positive;

         11. Subjects with clinical or radiological or laboratory evidence of active tuberculosis;

         12. Subjects with abnormal laboratory test results, meeting at least 1 of the following:

             12.1 Subjects with serum alanine aminotransferase (ALT) or glutamic-oxalacetic
             transaminase(AST)≥1.5 fold of the normal upper limit;

             12.2 Blood white blood cell count ≤4×10^9 / L;

             12.3 Platelet count ≤100 × 10^9 / L;

             12.4 Hemoglobin ≤85g / L;

             12.5 Other laboratory test abnormalities that may contribute to unacceptable risks for
             participants in this study;

         13. Subjects who are allergic to any of the investigational drugs;

         14. Use treatments and/or medication that are not allowed in this trial:

        14.1 History of leflunomide treatment for at least 3 months but not effective;

        14.2 Subjects who had undergone plasmapheresis or lymphocyte replacement or immunosorbent
        therapy in the last one year, or those who had planned to receive such treatments;

        14.3 Patients who are willing to receive attenuated vaccine during the trial;

        14.4 Subjects accepted or planned to have organ transplantation;
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

Lindi Jiang, Doctor, +86 135-6422-3680, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02981979

Organization ID

2016ZSLC-06


Responsible Party

Sponsor-Investigator

Study Sponsor

Jiang lindi


Study Sponsor

Lindi Jiang, Doctor, Principal Investigator, Shanghai Zhongshan Hospital


Verification Date

March 2018