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/NCT05962840</url>
    </required_header>
    <id_info>
      <org_study_id>CSTAR-K2956</org_study_id>
      <nct_id>NCT05962840</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)</brief_title>
    <official_title>A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the 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>
      <collaborator>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </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 investigate the remission rate of patients treated with&#xD;
        Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in&#xD;
        remission-maintain treatment.&#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 take Telitacicept as maintain&#xD;
        treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify&#xD;
        the effectiveness of Telitacicept in maintenance therapy of AAV.&#xD;
  &#xD;
        Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by&#xD;
        using from remission-induction treatment combined with Rituximab to maintenance treatment of&#xD;
        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">June 29, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2026</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, single-blinded, placebo-controlled, pilot study</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The time of first relapse during 24 months follow-up of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 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 24 months follow-up of two groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The time to remission of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The time from baseline to remission (disappearance of disease with a BVAS = 0) of patients of two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time from remission to first relapse of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The time from remission (disappearance of disease with a BVAS = 0) to first relapse (re-appearance of disease with a BVAS &gt;0) of patients of two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with sustained remission at months 12 and at months 24 of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The percentage of patients with sustained remission (disappearance of disease with a BVAS = 0) at months 12 and at months 24 of two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients with relapse at months 12 and at months 24 of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The percentage of patients with relapse (re-appearance of disease with a BVAS &gt;0), major relapse (re-appearance or worsening of disease with a BVAS &gt;0 and involvement of at least one major organ, a life-threatening manifestation, or both) and minor relapse (re-appearance of disease with a BVAS &gt;0 without involvement of major organ or a life-threatening manifestation) at months 12 and at months 24 of two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of adverse events and their severity in both treatment groups during 24 months of the study period.</measure>
      <time_frame>from inclusion to the end of the study, 24 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 treatment groups during the study period.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The percentage of patients who progress to ESRD at the end of the study</measure>
      <time_frame>from inclusion to the end of the study, 24 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 time of ANCA from positive to negative of two groups</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The time of ANCA from positive to negative of two groups</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The rate of complication of AAV in both treatment groups during 24 months of the study period.</measure>
      <time_frame>from inclusion to the end of the study, 24 months in total</time_frame>
      <description>The rate of complication of AAV in both treatment groups during 24 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>
    <arm_group>
      <arm_group_label>Placebo arm</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Telitacicept treatment arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Telitacicept</intervention_name>
      <description>Patient will be treated with Telitacicept (Taiai the commercial name) 80 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>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo of Telitacicept</intervention_name>
      <description>Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months</description>
      <arm_group_label>Placebo arm</arm_group_label>
    </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 have severe active AAV according to the 2021 ACR/vasculitis foundation&#xD;
               definition.&#xD;
  &#xD;
            4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their&#xD;
               disease.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who had been treated with Rituximab but had to stop due to adverse events or&#xD;
               intolerance.&#xD;
  &#xD;
            2. Patients who had other autoimmune diseases.&#xD;
  &#xD;
            3. 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;
            4. Patients who are pregnant or have planned for pregnancy in next 2 years.&#xD;
  &#xD;
            5. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal&#xD;
               infection.&#xD;
  &#xD;
            6. Patients with active hepatitis virus infection as well as patients who have active&#xD;
               mycobacteria infection.&#xD;
  &#xD;
            7. Patients with malignancy.&#xD;
  &#xD;
            8. Patients who are not eligible according to the judge of the principal 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, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Unione Mdecial College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yunjiao Yang, MD</last_name>
      <phone>86-13671313079</phone>
      <email>yangyunjiao81@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hanqi Wang, RN</last_name>
      <phone>86-15810927696</phone>
      <email>lijing6515@pumch.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yunjiao Yang, MD</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 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Telitacicept</keyword>
    <keyword>relapse rate</keyword>
    <keyword>remission maintain treatment</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>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Only patient clincial information coud be released to public</ipd_description>
    </patient_data>
    <!-- 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/NCT05962840
  org study id: CSTAR-K2956
  nct id: NCT05962840
  lead sponsor: 
  collaborator: 
  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 investigate the remission rate of patients treated with
        Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in
        remission-maintain treatment.
  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 take Telitacicept as maintain
        treatment in AAV patients who receive Rituximab as remission-induction treatment, to verify
        the effectiveness of Telitacicept in maintenance therapy of AAV.
  
        Objectives: To investigate the effectiveness of Telitacicept in reducing relapse rate by
        using from remission-induction treatment combined with Rituximab to 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, single-blinded, placebo-controlled, pilot study
  primary purpose: Treatment
  masking: Single (Participant)
  measure: The time of first relapse during 24 months follow-up of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The time from baseline to first relapse(re-appearance of disease with a BVAS >0) of patients during 24 months follow-up of two groups
  measure: The time to remission of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The time from baseline to remission (disappearance of disease with a BVAS = 0) of patients of two groups
  measure: The time from remission to first relapse of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The time from remission (disappearance of disease with a BVAS = 0) to first relapse (re-appearance of disease with a BVAS >0) of patients of two groups
  measure: The percentage of patients with sustained remission at months 12 and at months 24 of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The percentage of patients with sustained remission (disappearance of disease with a BVAS = 0) at months 12 and at months 24 of two groups
  measure: The percentage of patients with relapse at months 12 and at months 24 of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The percentage of patients with relapse (re-appearance of disease with a BVAS >0), major relapse (re-appearance or worsening of disease with a BVAS >0 and involvement of at least one major organ, a life-threatening manifestation, or both) and minor relapse (re-appearance of disease with a BVAS >0 without involvement of major organ or a life-threatening manifestation) at months 12 and at months 24 of two groups
  measure: The rate of adverse events and their severity in both treatment groups during 24 months of the study period.
  time frame: from inclusion to the end of the study, 24 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 treatment groups during the study period.
  measure: The percentage of patients who progress to ESRD at the end of the study
  time frame: from inclusion to the end of the study, 24 months in total
  description: The percentage of patients who progress to ESRD at the end of the study
  measure: The time of ANCA from positive to negative of two groups
  time frame: from inclusion to the end of the study, 24 months in total
  description: The time of ANCA from positive to negative of two groups
  measure: The rate of complication of AAV in both treatment groups during 24 months of the study period.
  time frame: from inclusion to the end of the study, 24 months in total
  description: The rate of complication of AAV in both treatment groups during 24 months of the study period.
  arm group label: Placebo arm
  arm group type: Placebo Comparator
  description: Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
  arm group label: Telitacicept treatment arm
  arm group type: Experimental
  description: Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)
  intervention type: Drug
  intervention name: Telitacicept
  description: Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
  arm group label: Telitacicept treatment arm
  other name: Taiai for commercial name
  intervention type: Other
  intervention name: Placebo of Telitacicept
  description: Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months
  arm group label: Placebo arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  last name: Jing Li, MD
  role: Principal Investigator
  affiliation: Peking Unione Mdecial College Hospital
  last name: Yunjiao Yang, MD
  phone: 86-13671313079
  email: yangyunjiao81@163.com
  last name: Hanqi Wang, RN
  phone: 86-15810927696
  email: lijing6515@pumch.cn
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Sponsor
  mesh term: Vasculitis
  mesh term: Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  sharing ipd: No
  ipd description: Only patient clincial information coud be released to public