xml: <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/NCT05965284</url>
    </required_header>
    <id_info>
      <org_study_id>CSTAR-K2374</org_study_id>
      <nct_id>NCT05965284</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis (TTCAZAREM)</brief_title>
    <official_title>A Prospective, Open-label, Controlled, Single Center Clinical Study of the Efficacy and Safety for Telitacicept in the Remission Maintenance Treatment of ANCA-associated Vasculitis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese SLE Treatment And Research Group</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese SLE Treatment And Research Group</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a prospective, open-labelled, randomized, controlled, single-center clinical&#xD;
        trial. The aim of this study is to compare the remission rate of patients treated with&#xD;
        Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance&#xD;
        treatment of AAV.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV&#xD;
        aimed to reduce or prevent relapse is very challenge. Although many medications have been&#xD;
        used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has&#xD;
        been proved to be effect in treatment of SLE) has not been studied yet. One study tested the&#xD;
        efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as&#xD;
        remission-induction treatment, no relapse was observed. However, the sample size of this&#xD;
        study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on&#xD;
        APRIL.&#xD;
  &#xD;
        Many experiences have been accumulated about the efficacy and safety of Telitacicept in&#xD;
        Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in&#xD;
        the reduction of the relapse of AAV in China. In this study, we add Telitacicept to&#xD;
        azathioprine in maintain treatment in AAV patients who receive Rituximab as&#xD;
        remission-induction treatment, to compare the relapse rates of Telitacicept combining&#xD;
        azathioprine and azathioprine alone in maintenance therapy of AAV.&#xD;
  &#xD;
        Objectives: To compare the relapse rates of Telitacicept combining azathioprine and&#xD;
        azathioprine alone in maintenance treatment of AAV.&#xD;
  &#xD;
        Study Design: This is a prospective, randomized, open-label, control, pilot study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 9, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>prospective, randomized, open-label, control, pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The time of first relapse during 12 months follow-up of two groups</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The time from baseline to first relapse(re-appearance of disease with a BVAS &gt;0) of patients during 12 months follow-up of two groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with severe relapse at months 12</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The percentage of patients with severe relapse (re-appearance or worsening of disease with a BVAS ≥6 and involvement of at least one major organ, a life-threatening manifestation, or both) at months 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with moderate relapse at months 12</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The percentage of patients with moderate relapse (re-appearance or worsening of disease with a BVAS ≥3 without involvement of major organ or life-threatening manifestation) at months 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with mild relapse at months 12</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The percentage of patients with mild relapse (re-appearance or worsening of disease with a 0 &lt; BVAS &lt; 3 without involvement of major organ or life-threatening manifestation) at months 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with sustained remission at months 12</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of adverse events</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The rate of adverse events and their severity (Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both two groups during the study period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients who progress to ESRD</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The percentage of patients who progress to ESRD at the end of the study</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of complication of AAV</measure>
      <time_frame>from inclusion to the end of the study, 12 months in total</time_frame>
      <description>The rate of complication of AAV in both treatment groups during 12 months of the study period.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>ANCA-associated Vasculitis</condition>
    <condition>Maintenance Therapy</condition>
    <arm_group>
      <arm_group_label>Azathioprine treatment arm</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Telitacicept treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Azathioprine</intervention_name>
      <description>All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.</description>
      <arm_group_label>Azathioprine treatment arm</arm_group_label>
      <arm_group_label>Telitacicept treatment arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Telitacicept</intervention_name>
      <description>Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months</description>
      <arm_group_label>Telitacicept treatment arm</arm_group_label>
      <other_name>Taiai for commercial name</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients age 18 to 65 years, both genders can be included.&#xD;
  &#xD;
            2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or&#xD;
               microscopic polyangiitis must fulfill the 2022 ACR/EULAR classification criteria of&#xD;
               GPA or MPA.&#xD;
  &#xD;
            3. Patients who are in complete remission after combined treatment with glucocorticoids&#xD;
               and Rituximab. Remission is defined as a Birmingham Vasculitis Activity Score (BVAS&#xD;
               version 3) of 0. And the daily dosage of prednisone are no more than 10mg (or&#xD;
               equivalent).&#xD;
  &#xD;
            4. Patients have to be ANCA-positive at diagnosis or during the course of their disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients with TPMT gene mutation.&#xD;
  &#xD;
            2. Patients who had been treated with either AZA but relapsed in the past.&#xD;
  &#xD;
            3. Patients who had been treated with either AZA but had to stop due to adverse events or&#xD;
               intolerance.&#xD;
  &#xD;
            4. Patients who have planned for pregnancy in next 1.5 years.&#xD;
  &#xD;
            5. Patients with severe liver dysfunction(defined as the 2-folds elevation of normal&#xD;
               upper limit or Child grade III), heart failure or ESRD(eGFR&lt;30ml/min).&#xD;
  &#xD;
            6. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal&#xD;
               infection;&#xD;
  &#xD;
            7. Patients with active hepatitis virus infection as well as patients who have active&#xD;
               mycobacteria infection;&#xD;
  &#xD;
            8. Patients who had other autoimmune diseases.&#xD;
  &#xD;
            9. Patients with malignancy.&#xD;
  &#xD;
           10. Patients who are not eligible according to the judge of the principal investigators or&#xD;
               site investigators.&#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>JIng Li, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Unione Mdecial College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yunjiao Yang, M.D.</last_name>
      <phone>+86-13671313079</phone>
      <email>yangyunjiao81@163.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yunjiao Yang, M.D.</last_name>
        <phone>86-13671313079</phone>
        <email>yangyunjiao81@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Hanqi Wang, RN</last_name>
        <phone>86-15810927696</phone>
        <email>lijing6515@pumch.cn</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>ANCA-associated Vasculitis</keyword>
    <keyword>Telitacicept</keyword>
    <keyword>Azathioprine</keyword>
    <keyword>Relapse rate</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Vasculitis</mesh_term>
      <mesh_term>Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Azathioprine</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05965284
  org study id: CSTAR-K2374
  nct id: NCT05965284
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective, open-labelled, randomized, controlled, single-center clinical
        trial. The aim of this study is to compare the remission rate of patients treated with
        Telitacicept combined with azathioprine and azathioprine alone in remission-maintenance
        treatment of AAV.
  Background: The basic theme of AAV is relapse and remission. The maintenance therapy of AAV
        aimed to reduce or prevent relapse is very challenge. Although many medications have been
        used for the maintenance of AAV, Telitacicept (a BAFF/APRIL dual-target-inhibitor, which has
        been proved to be effect in treatment of SLE) has not been studied yet. One study tested the
        efficacy of Belimumab in the maintenance therapy for AAV. When taken Rituximab as
        remission-induction treatment, no relapse was observed. However, the sample size of this
        study is small, and the Belimumab, as a BAFF inhibitor, was not been proved to have effect on
        APRIL.
  
        Many experiences have been accumulated about the efficacy and safety of Telitacicept in
        Chinese patients with rheumatic diseases. But there is no study to show its effectiveness in
        the reduction of the relapse of AAV in China. In this study, we add Telitacicept to
        azathioprine in maintain treatment in AAV patients who receive Rituximab as
        remission-induction treatment, to compare the relapse rates of Telitacicept combining
        azathioprine and azathioprine alone in maintenance therapy of AAV.
  
        Objectives: To compare the relapse rates of Telitacicept combining azathioprine and
        azathioprine alone in maintenance treatment of AAV.
  
        Study Design: This is a prospective, randomized, open-label, control, pilot study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: prospective, randomized, open-label, control, pilot study
  primary purpose: Treatment
  masking: None (Open Label)
  measure: The time of first relapse during 12 months follow-up of two groups
  time frame: from inclusion to the end of the study, 12 months in total
  description: The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 12 months follow-up of two groups
  measure: The percentage of patients with severe relapse at months 12
  time frame: from inclusion to the end of the study, 12 months in total
  description: The percentage of patients with severe relapse (re-appearance or worsening of disease with a BVAS ≥6 and involvement of at least one major organ, a life-threatening manifestation, or both) at months 12
  measure: The percentage of patients with moderate relapse at months 12
  time frame: from inclusion to the end of the study, 12 months in total
  description: The percentage of patients with moderate relapse (re-appearance or worsening of disease with a BVAS ≥3 without involvement of major organ or life-threatening manifestation) at months 12
  measure: The percentage of patients with mild relapse at months 12
  time frame: from inclusion to the end of the study, 12 months in total
  description: The percentage of patients with mild relapse (re-appearance or worsening of disease with a 0 < BVAS < 3 without involvement of major organ or life-threatening manifestation) at months 12
  measure: The percentage of patients with sustained remission at months 12
  time frame: from inclusion to the end of the study, 12 months in total
  description: The percentage of patients with sustained remission (BVAS =0 without dosage increase of glucocorticoid) at months 12
  measure: The rate of adverse events
  time frame: from inclusion to the end of the study, 12 months in total
  description: The rate of adverse events and their severity (Severe events were defined as the adverse events of grade 3 or 4, deaths caused by any cause, cancers, side effects that necessitate hospitalization) in both two groups during the study period.
  measure: The percentage of patients who progress to ESRD
  time frame: from inclusion to the end of the study, 12 months in total
  description: The percentage of patients who progress to ESRD at the end of the study
  measure: The rate of complication of AAV
  time frame: from inclusion to the end of the study, 12 months in total
  description: The rate of complication of AAV in both treatment groups during 12 months of the study period.
  arm group label: Azathioprine treatment arm
  arm group type: Other
  description: Patients will be treated with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
  arm group label: Telitacicept treatment arm
  arm group type: Experimental
  description: Patients will be treated with Telitacicept 160mg per week combined with Azathioprine 100mg per day for 12 months combined with prednisone no more than 10mg daily. The dosage of prednisone is tapered in the study period while sustained remission achieved. All included patients will be treated with TMPco 2 tablets per day during the study period if not contraindicated or intolerant.
  intervention type: Drug
  intervention name: Azathioprine
  description: All patients included into this study will be treated with Azathioprine tablets 100mg QD for 12 months.
  arm group label: Azathioprine treatment arm
  arm group label: Telitacicept treatment arm
  intervention type: Drug
  intervention name: Telitacicept
  description: Patient will be treated with Telitacicept (Taiai the commercial name) 160 mg every week subcutaneously for 12 months
  arm group label: Telitacicept treatment arm
  other name: Taiai for commercial name
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: JIng Li, M.D.
  role: Principal Investigator
  affiliation: Peking Unione Mdecial College Hospital
  last name: Yunjiao Yang, M.D.
  phone: +86-13671313079
  email: yangyunjiao81@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Vasculitis
  mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  mesh term: Azathioprine