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/NCT05998759</url>
    </required_header>
    <id_info>
      <org_study_id>BJ-2021-235</org_study_id>
      <secondary_id>BJ-2021-235</secondary_id>
      <secondary_id>RCTAIIRCTD001</secondary_id>
      <nct_id>NCT05998759</nct_id>
    </id_info>
    <brief_title>Telitacicept for the Treatment of Connective Tissue Disease-associated Thrombocytopenia</brief_title>
    <official_title>A Randomized, Double-blind Placebo-controlled Study of Recombinant Human B Lymphocyte Stimulating Factor Receptor-Fc Fusion Protein for the Treatment of Connective Tissue Disease-associated Thrombocytopenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Guangdong Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First Affiliated Hospital of Zhengzhou University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuhan Union Hospital, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Second Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Xiangya Hospital of Central South University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The Affiliated Hospital of Inner Mongolia Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Hospital of China Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shandong Provincial Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Changhai Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shanxi Bethune Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Institute of Hematology &amp; Blood Diseases Hospital, China</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin First Central Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>People's Hospital of Xinjiang Uygur Autonomous Region</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>The First People's Hospital of Yunnan</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Beijing Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for&#xD;
        the treatment of connective tissue disease-associated thrombocytopenia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this randomized, double-blind placebo-controlled study, the investigators aim to evaluate&#xD;
        the efficacy and safety of Telitacicept for the treatment of connective tissue&#xD;
        disease-associated thrombocytopenia. After screening, eligible participants will be&#xD;
        randomized at a 1: 1 ratio to receive either subcutaneous Telitacicept 160 mg or placebo once&#xD;
        a week for 24 weeks. The background standard therapy is maintained stable during the whole&#xD;
        treatment period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall response (CR + PR) rate</measure>
      <time_frame>at week 24</time_frame>
      <description>Response is deemed as complete (CR) if the platelet (PLT) count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall response (CR + PR) rate</measure>
      <time_frame>at week 12</time_frame>
      <description>Response is deemed as complete (CR) if the platelet count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rescue treatment rate</measure>
      <time_frame>at week 24</time_frame>
      <description>Rescue treatment is initiated if the platelet count is &lt;10×10^9/L, or the participant is with active bleeding, or based on the investigator's judgement when the platelet count ranges from 10×10^9/L to 20×10^9/L.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to rescue treatment</measure>
      <time_frame>at week 24</time_frame>
      <description>Time to rescue treatment refers to period duration from the initiation of Telitacicept or placebo (day 1) to rescue treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relapse rate</measure>
      <time_frame>at week 24</time_frame>
      <description>No response refers to the platelet count is &lt; 50×10^9/L, or increases for less than 1-fold from baseline, or with active central nervous system or digestive tract bleeding, or rescue treatment is initiated. Relapse is defined as no response recurring after a complete or partial response lasting for at least 7 days with treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to relapse</measure>
      <time_frame>at week 24</time_frame>
      <description>Time to relapse refers to period duration from the initiation of Telitacicept or placebo (day 1) to relapse.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>treatment related adverse event</measure>
      <time_frame>at week 24</time_frame>
      <description>According to the NCI CTCAE 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>treatment related severe adverse event</measure>
      <time_frame>at week 24</time_frame>
      <description>According to the NCI CTCAE 5.0</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>bleeding scale</measure>
      <time_frame>at week 24</time_frame>
      <description>According to the ITP bleeding scale (IBLS). The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>life quality 1</measure>
      <time_frame>at week 24</time_frame>
      <description>According to the ITP Patient Assessment Questionnaire™ (ITP-PAQ™) score. The ITP-PAQ™ is a disease-specific instrument that was designed to measure the Quality of Life (QoL) of adult patients with immune thrombocytopenia. The items employ a 4-week recall with responses recorded on 4-, 5- or 7-point Likert scales. All item scores are transformed to a 0 to 100 continuum where higher scores represent better QoL and are weighted equally to derive the scale scores.</description>
    </other_outcome>
    <other_outcome>
      <measure>life quality 2</measure>
      <time_frame>at week 24</time_frame>
      <description>According to the FACT-Th6 score. The Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Items were reverse-scored as necessary such that higher scores represent higher Health-related quality of life (HRQoL). Total scores ranged from 0 to 24. Recall period is previous 7 days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum immunoglobulin G (IgG)</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum IgG level at week 24-serum IgG level at baseline)/ serum IgG level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum immunoglobulin M (IgM)</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum IgM level at week 24-serum IgM level at baseline)/ serum IgM level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum immunoglobulin A (IgA)</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum IgA level at week 24-serum IgA level at baseline)/ serum IgA level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum C3</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum C3 level at week 24-serum C3 level at baseline)/ serum C3 level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum C4</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum C4 level at week 24-serum C4 level at baseline)/ serum C4 level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum anti-platelet antibody</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum anti-platelet antibody level at week 24-serum anti-platelet antibody level at baseline)/ serum anti-platelet antibody level at baseline</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum Blys</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum Blys level at week 24-serum Blys level at baseline)/ serum Blys level at baseline. Blys is short for B lymphocyte stimulator.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in serum APRIL</measure>
      <time_frame>at week 24</time_frame>
      <description>(serum APRIL level at week 24-serum APRIL level at baseline)/ serum APRIL level at baseline. APRIL is short for a proliferation-inducing ligand.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in peripheral naive B cell count</measure>
      <time_frame>at week 24</time_frame>
      <description>(peripheral naive B cell count at week 24-peripheral naive B cell count at baseline)/ peripheral naive B cell count at baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in peripheral plasma cell count</measure>
      <time_frame>at week 24</time_frame>
      <description>(peripheral plasma cell count at week 24-peripheral plasma cell count at baseline)/ peripheral plasma cell count at baseline.</description>
    </other_outcome>
    <other_outcome>
      <measure>Absolute change rate from baseline in peripheral plasmablast count</measure>
      <time_frame>at week 24</time_frame>
      <description>(peripheral plasmablast count at week 24-peripheral plasmablast count at baseline)/ peripheral plasmablast count at baseline.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">296</enrollment>
    <condition>Connective Tissue Diseases</condition>
    <condition>Thrombocytopenia</condition>
    <arm_group>
      <arm_group_label>Telitacicept plus standard therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Telitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo plus standard therapy</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Placebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Telitacicept</intervention_name>
      <description>subcutaneous telitacicept 160 mg weekly for 24 weeks.</description>
      <arm_group_label>Telitacicept plus standard therapy</arm_group_label>
      <other_name>recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein</other_name>
      <other_name>Recombinant Human B Lymphocyte(RC18)</other_name>
      <other_name>Tai'ai®</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>subcutaneous placebo weekly for 24 weeks.</description>
      <arm_group_label>Placebo plus standard therapy</arm_group_label>
      <other_name>Placebo control</other_name>
      <other_name>control</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects who have been diagnosed with connective tissue disease (CTD)-associated&#xD;
               thrombocytopenia. And CTD includes primary Sjögren syndrome (according to the 2002&#xD;
               American College of Rheumatology (ACR)/ European League against Rheumatism (EULAR)&#xD;
               classification criteria), systemic lupus erythematosus (SLE, according to the 1997 or&#xD;
               the 2009 ACR classification criteria), and undifferentiated connective tissue disease&#xD;
               (according to the 1999 international classification criteria)&#xD;
  &#xD;
            -  Refractory thrombocytopenia defined as:&#xD;
  &#xD;
          Either: Failure to maintain sustained remission after treatment by oral glucocorticoid dose&#xD;
          ≥1 mg/kg/day for at least 4 weeks (prednisone or equivalent) and at least one&#xD;
          immunosuppressant (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil,&#xD;
          azathioprine, tacrolimus, methotrexate, leflunomide and hydroxychloroquine, et al.) Or:&#xD;
          Relapse during oral glucocorticoid tapering or after withdrawal&#xD;
  &#xD;
            -  50×10^9/L&gt;PLT ≥20×10^9/L&#xD;
  &#xD;
            -  anti-nuclear antibody (ANA) positive (≥1:80, any karyotype) detected in the laboratory&#xD;
               of each research center&#xD;
  &#xD;
            -  Standard therapy should be maintained stable for at least 28 days prior to the first&#xD;
               dose of the experimental drug or placebo. Standard therapy refers to the following&#xD;
               treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and&#xD;
               other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil,&#xD;
               azathioprine, tacrolimus, methotrexate and leflunomide, et al.)&#xD;
  &#xD;
            -  Signed informed consent form, willing or able to participate in all required study&#xD;
               evaluations and procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vital organ lethal bleeding (including but not limited to central nervous system&#xD;
               bleeding, digestive tract bleeding) at screening, or intracranial bleeding 6 months&#xD;
               prior to screening&#xD;
  &#xD;
            -  Antiphospholipid syndrome, thrombotic thrombocytopenia purpura, hemolytic uremic&#xD;
               syndrome, or thrombocytopenia secondary to other causes (such as sepsis, Epstein-Barr&#xD;
               virus infection, cytomegalovirus infection, Corona Virus Disease-19 (COVID-19)&#xD;
               infection, drugs, etc.)&#xD;
  &#xD;
            -  Hematopoietic system disorders, such as myelodysplastic syndrome, paroxysmal sleep&#xD;
               hemoglobinuria, aplastic anemia, leukemia, lymphoma, myelofibrosis and so on&#xD;
  &#xD;
            -  Severe cardiovascular system disease, including: unstable or uncontrollable disease or&#xD;
               condition affecting the function of the heart (such as angina pectoris, congestive&#xD;
               heart failure, uncontrolled hypertension or arrhythmia)&#xD;
  &#xD;
            -  Arteriovenous thromboembolism events&#xD;
  &#xD;
            -  Receiving antiplatelet or anticoagulant therapy at screening&#xD;
  &#xD;
            -  Clinically significant electrocardiogram changes&#xD;
  &#xD;
            -  corrected Q-T interval (QTc)&gt;450ms for male, QTc&gt;470ms for female&#xD;
  &#xD;
            -  Severe pulmonary disease, including: unstable or uncontrollable disease or condition&#xD;
               affecting respiratory function [e.g., diffuse alveolar hemorrhage, severe pulmonary&#xD;
               hypertension, severe pulmonary interstitial disease (peripheral blood oxygen&#xD;
               saturation &lt;92% at rest without oxygen, or forced vital capacity (FVC)&lt;50%, or carbon&#xD;
               monoxide diffusing capacity (DLCO)&lt;50%)]&#xD;
  &#xD;
            -  Severe kidney disease, including: severe lupus nephritis (urinary protein &gt; 6 g/24&#xD;
               hours or endogenous creatinine clearance &lt; 30 ml /min) 8 weeks prior to randomization,&#xD;
               active nephritis requiring current protocol disallowed drugs, severe renal&#xD;
               insufficiency requiring hemodialysis or prednisone ≥100mg/ day (or equivalent) for ≥14&#xD;
               days&#xD;
  &#xD;
            -  SLE or non-SLE related central nervous system disease (including epilepsy, psychosis,&#xD;
               organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central&#xD;
               nervous system vasculitis) 8 weeks prior to randomization&#xD;
  &#xD;
            -  Active hepatitis, a history of severe liver disease. Subjects positive for hepatitis B&#xD;
               surface antigen (HBsAg) or antibodies to hepatitis C virus are excluded. As for&#xD;
               subjects with antibodies to hepatitis B core antigen (HBcAb), further hepatitis B&#xD;
               virus (HBV)-DNA should be tested. If HBV-DNA is negative, subjects could be enrolled;&#xD;
               otherwise, subjects should be excluded&#xD;
  &#xD;
            -  Abnormal laboratory results (including but not limited to: alanine aminotransferase&#xD;
               (ALT) or aspertate aminotransferase (AST)≥3×ULN (upper limit of normal), white blood&#xD;
               cell count &lt;1.5×10^9/L)&#xD;
  &#xD;
            -  Subjects with known active infections (e.g., shingles, COVID-19, HIV, active&#xD;
               tuberculosis, etc.), and active or recurrent gastrointestinal ulcers&#xD;
  &#xD;
            -  Pregnant or lactating women, and subjects with a during plan during the trial&#xD;
  &#xD;
            -  Allergic reaction: history of allergic reactions to human biological products&#xD;
  &#xD;
            -  Treatment with B cell-targeting agents such as Rituximab or Epratuzumab or Belimumab&#xD;
               six months prior to randomization&#xD;
  &#xD;
            -  Treatment with tumor necrosis factor (TNF) inhibitors or TNF-receptor blockers six&#xD;
               months prior to randomization&#xD;
  &#xD;
            -  Participating in clinical trial 28 days or 5 drug half-lives of the investigational&#xD;
               agents prior to randomization&#xD;
  &#xD;
            -  Received live vaccine 28 days prior to randomization&#xD;
  &#xD;
            -  Treatment with thrombopoietin receptor agonists such as Eltrombopag or Romiplostim 28&#xD;
               days prior to randomization&#xD;
  &#xD;
            -  Subjects with depression or suicidal thoughts&#xD;
  &#xD;
            -  Previous treatment with telitacicept&#xD;
  &#xD;
            -  B cell targeting drug therapy is not tolerated or responsive&#xD;
  &#xD;
            -  Investigator considers candidates not appropriating for the study&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Xuan Zhang, MD.</last_name>
      <role>Study Chair</role>
      <affiliation>Beijing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yongjing Cheng, MD.</last_name>
      <role>Study Chair</role>
      <affiliation>Beijing Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Zhu Chen, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Jing He, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University People's Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Rong Mu, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Niansheng Yang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Affiliated Hospital, Sun Yat-Sen University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Yang Li, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Guangdong Provincial People's Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Shengyun Liu, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First Affiliated Hospital of Zhengzhou University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Anbin Huang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Wuhan Union Hospital, China</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Fen Li, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Second Xiangya Hospital of Central South University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hui Luo, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Xiangya Hospital of Central South University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongbin Li, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The Affiliated Hospital of Inner Mongolia Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Pinting Yang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>First Hospital of China Medical University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Hongsheng Sun, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shandong Provincial Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Dongbao Zhao, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Changhai Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Sheng Chen, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>RenJi Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Liyun Zhang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Shanxi Bethune Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qibing Xie, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>West China Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lei Zhang, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Institute of Hematology &amp; Blood Diseases Hospital, China</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wufang Qi, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin First Central Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Wei Wei, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Tianjin Medical University General Hospital</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lijun Wu, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>People's Hospital of Xinjiang Uygur Autonomous Region</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qin Li, MD.</last_name>
      <role>Principal Investigator</role>
      <affiliation>The First People's Hospital of Yunnan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xuan Zhang, MD.</last_name>
      <phone>+86-01085136736</phone>
      <email>zxpumch2003@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yongjing Cheng, MD.</last_name>
      <phone>+86-01085136736</phone>
      <email>chengyongjing3427@njhmoh.cn</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Zhu Chen, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Beijing Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Xuan Zhang, MD.</last_name>
      </contact>
      <contact_backup>
        <last_name>Yongjing Cheng, MD.</last_name>
      </contact_backup>
      <investigator>
        <last_name>Like Zhao, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Zhe Chen, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ru Feng, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Fang Wang, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yingjuan Chen, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Min Wang, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Qian Wang, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Min Feng, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yanxiang Luo, MD.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Peking University People's Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jing He, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Rong Mu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital, Sun Yat-Sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Niansheng Yang, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Guangdong Provincial People's Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Yang Li, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Shengyun Liu, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Wuhan Union Hospital, China</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Anbin Huang, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Second Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Fen Li, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hui Luo, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Inner Mongolia Medical University</name>
        <address>
          <city>Hohhot</city>
          <state>Inner Mongolia Autonomous Region</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongbin Li, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Pinting Yang, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shandong Provincial Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Hongsheng Sun, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Changhai Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Dongbao Zhao, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>RenJi Hospital</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Sheng Chen, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shanxi Bethune Hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Liyun Zhang, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qibing Xie, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Institute of Hematology &amp; Blood Diseases Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lei Zhang, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin First Central Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wufang Qi, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Tianjin Medical University General Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Wei Wei, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>People's Hospital of Xinjiang Uygur Autonomous Region</name>
        <address>
          <city>Ürümqi</city>
          <state>Xinjiang Uygur Autonomous Region</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Lijun Wu, MD.</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First People's Hospital of Yunnan</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Qin Li, MD.</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Beijing Hospital</investigator_affiliation>
      <investigator_full_name>Yongjing Cheng</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Connective Tissue Diseases</keyword>
    <keyword>Thrombocytopenia</keyword>
    <keyword>biological agents</keyword>
    <keyword>B cell</keyword>
    <keyword>targeted therapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Thrombocytopenia</mesh_term>
      <mesh_term>Connective Tissue Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05998759
  org study id: BJ-2021-235
  secondary id: BJ-2021-235
  secondary id: RCTAIIRCTD001
  nct id: NCT05998759
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  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to evaluate the efficacy and safety of Telitacicept for
        the treatment of connective tissue disease-associated thrombocytopenia.
  In this randomized, double-blind placebo-controlled study, the investigators aim to evaluate
        the efficacy and safety of Telitacicept for the treatment of connective tissue
        disease-associated thrombocytopenia. After screening, eligible participants will be
        randomized at a 1: 1 ratio to receive either subcutaneous Telitacicept 160 mg or placebo once
        a week for 24 weeks. The background standard therapy is maintained stable during the whole
        treatment period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Overall response (CR + PR) rate
  time frame: at week 24
  description: Response is deemed as complete (CR) if the platelet (PLT) count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
  measure: Overall response (CR + PR) rate
  time frame: at week 12
  description: Response is deemed as complete (CR) if the platelet count is ≥ 100×10^9/L, partial (PR) if the platelet count ranges from 50×10^9/L to 100×10^9/L and at least doubled from baseline. No active bleeding is allowed in participants classified as CR or PR.
  measure: Rescue treatment rate
  time frame: at week 24
  description: Rescue treatment is initiated if the platelet count is <10×10^9/L, or the participant is with active bleeding, or based on the investigator's judgement when the platelet count ranges from 10×10^9/L to 20×10^9/L.
  measure: Time to rescue treatment
  time frame: at week 24
  description: Time to rescue treatment refers to period duration from the initiation of Telitacicept or placebo (day 1) to rescue treatment.
  measure: Relapse rate
  time frame: at week 24
  description: No response refers to the platelet count is < 50×10^9/L, or increases for less than 1-fold from baseline, or with active central nervous system or digestive tract bleeding, or rescue treatment is initiated. Relapse is defined as no response recurring after a complete or partial response lasting for at least 7 days with treatment.
  measure: Time to relapse
  time frame: at week 24
  description: Time to relapse refers to period duration from the initiation of Telitacicept or placebo (day 1) to relapse.
  measure: treatment related adverse event
  time frame: at week 24
  description: According to the NCI CTCAE 5.0
  measure: treatment related severe adverse event
  time frame: at week 24
  description: According to the NCI CTCAE 5.0
  measure: bleeding scale
  time frame: at week 24
  description: According to the ITP bleeding scale (IBLS). The IBLS comprises of 11 grades from 0 (none) to 2 (marked bleeding) by history over the previous week or by exam; 2 being worse. These 11 grades include: skin by physical exam, oral by physical exam, skin by history, oral by history, epistaxis, gastrointestinal, urinary, gynecological, pulmonary, intracranial hemorrhage, and subconjunctival hemorrhage.
  measure: life quality 1
  time frame: at week 24
  description: According to the ITP Patient Assessment Questionnaire™ (ITP-PAQ™) score. The ITP-PAQ™ is a disease-specific instrument that was designed to measure the Quality of Life (QoL) of adult patients with immune thrombocytopenia. The items employ a 4-week recall with responses recorded on 4-, 5- or 7-point Likert scales. All item scores are transformed to a 0 to 100 continuum where higher scores represent better QoL and are weighted equally to derive the scale scores.
  measure: life quality 2
  time frame: at week 24
  description: According to the FACT-Th6 score. The Functional Assessment of Cancer Therapy-Thrombocytopenia (FACT-Th6) consists of 6 questions in which patients rate (0-4) their general degree of worry related to bleeding and bruising, and resulting activity impairment and frustration. Items were reverse-scored as necessary such that higher scores represent higher Health-related quality of life (HRQoL). Total scores ranged from 0 to 24. Recall period is previous 7 days.
  measure: Absolute change rate from baseline in serum immunoglobulin G (IgG)
  time frame: at week 24
  description: (serum IgG level at week 24-serum IgG level at baseline)/ serum IgG level at baseline
  measure: Absolute change rate from baseline in serum immunoglobulin M (IgM)
  time frame: at week 24
  description: (serum IgM level at week 24-serum IgM level at baseline)/ serum IgM level at baseline
  measure: Absolute change rate from baseline in serum immunoglobulin A (IgA)
  time frame: at week 24
  description: (serum IgA level at week 24-serum IgA level at baseline)/ serum IgA level at baseline
  measure: Absolute change rate from baseline in serum C3
  time frame: at week 24
  description: (serum C3 level at week 24-serum C3 level at baseline)/ serum C3 level at baseline
  measure: Absolute change rate from baseline in serum C4
  time frame: at week 24
  description: (serum C4 level at week 24-serum C4 level at baseline)/ serum C4 level at baseline
  measure: Absolute change rate from baseline in serum anti-platelet antibody
  time frame: at week 24
  description: (serum anti-platelet antibody level at week 24-serum anti-platelet antibody level at baseline)/ serum anti-platelet antibody level at baseline
  measure: Absolute change rate from baseline in serum Blys
  time frame: at week 24
  description: (serum Blys level at week 24-serum Blys level at baseline)/ serum Blys level at baseline. Blys is short for B lymphocyte stimulator.
  measure: Absolute change rate from baseline in serum APRIL
  time frame: at week 24
  description: (serum APRIL level at week 24-serum APRIL level at baseline)/ serum APRIL level at baseline. APRIL is short for a proliferation-inducing ligand.
  measure: Absolute change rate from baseline in peripheral naive B cell count
  time frame: at week 24
  description: (peripheral naive B cell count at week 24-peripheral naive B cell count at baseline)/ peripheral naive B cell count at baseline.
  measure: Absolute change rate from baseline in peripheral plasma cell count
  time frame: at week 24
  description: (peripheral plasma cell count at week 24-peripheral plasma cell count at baseline)/ peripheral plasma cell count at baseline.
  measure: Absolute change rate from baseline in peripheral plasmablast count
  time frame: at week 24
  description: (peripheral plasmablast count at week 24-peripheral plasmablast count at baseline)/ peripheral plasmablast count at baseline.
  arm group label: Telitacicept plus standard therapy
  arm group type: Experimental
  description: Telitacicept (160mg ih qw for 24 weeks) combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).
  arm group label: Placebo plus standard therapy
  arm group type: Placebo Comparator
  description: Placebo combined with standard therapy. Standard therapy refers to the following treatment (monotherapy or in combination): glucocorticoid, hydroxychloroquine, and other immunosuppressants (i.e. cyclophosphamide, cyclosporine, mycophenolate mofetil, azathioprine, tacrolimus, methotrexate and leflunomide, et al.).
  intervention type: Biological
  intervention name: Telitacicept
  description: subcutaneous telitacicept 160 mg weekly for 24 weeks.
  arm group label: Telitacicept plus standard therapy
  other name: recombinant human B lymphocyte stimulating factor receptor-Fc fusion protein
  other name: Recombinant Human B Lymphocyte(RC18)
  other name: Tai'ai®
  intervention type: Drug
  intervention name: Placebo
  description: subcutaneous placebo weekly for 24 weeks.
  arm group label: Placebo plus standard therapy
  other name: Placebo control
  other name: control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Xuan Zhang, MD.
  role: Study Chair
  affiliation: Beijing Hospital
  last name: Yongjing Cheng, MD.
  role: Study Chair
  affiliation: Beijing Hospital
  last name: Zhu Chen, MD.
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial)
  last name: Jing He, MD.
  role: Principal Investigator
  affiliation: Peking University People's Hospital
  last name: Rong Mu, MD.
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Niansheng Yang, MD.
  role: Principal Investigator
  affiliation: First Affiliated Hospital, Sun Yat-Sen University
  last name: Yang Li, MD.
  role: Principal Investigator
  affiliation: Guangdong Provincial People's Hospital
  last name: Shengyun Liu, MD.
  role: Principal Investigator
  affiliation: The First Affiliated Hospital of Zhengzhou University
  last name: Anbin Huang, MD.
  role: Principal Investigator
  affiliation: Wuhan Union Hospital, China
  last name: Fen Li, MD.
  role: Principal Investigator
  affiliation: Second Xiangya Hospital of Central South University
  last name: Hui Luo, MD.
  role: Principal Investigator
  affiliation: Xiangya Hospital of Central South University
  last name: Hongbin Li, MD.
  role: Principal Investigator
  affiliation: The Affiliated Hospital of Inner Mongolia Medical University
  last name: Pinting Yang, MD.
  role: Principal Investigator
  affiliation: First Hospital of China Medical University
  last name: Hongsheng Sun, MD.
  role: Principal Investigator
  affiliation: Shandong Provincial Hospital
  last name: Dongbao Zhao, MD.
  role: Principal Investigator
  affiliation: Changhai Hospital
  last name: Sheng Chen, MD.
  role: Principal Investigator
  affiliation: RenJi Hospital
  last name: Liyun Zhang, MD.
  role: Principal Investigator
  affiliation: Shanxi Bethune Hospital
  last name: Qibing Xie, MD.
  role: Principal Investigator
  affiliation: West China Hospital
  last name: Lei Zhang, MD.
  role: Principal Investigator
  affiliation: Institute of Hematology & Blood Diseases Hospital, China
  last name: Wufang Qi, MD.
  role: Principal Investigator
  affiliation: Tianjin First Central Hospital
  last name: Wei Wei, MD.
  role: Principal Investigator
  affiliation: Tianjin Medical University General Hospital
  last name: Lijun Wu, MD.
  role: Principal Investigator
  affiliation: People's Hospital of Xinjiang Uygur Autonomous Region
  last name: Qin Li, MD.
  role: Principal Investigator
  affiliation: The First People's Hospital of Yunnan
  last name: Xuan Zhang, MD.
  phone: +86-01085136736
  email: zxpumch2003@sina.com
  last name: Yongjing Cheng, MD.
  phone: +86-01085136736
  email: chengyongjing3427@njhmoh.cn
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  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Beijing Hospital
  investigator full name: Yongjing Cheng
  investigator title: Professor
  mesh term: Thrombocytopenia
  mesh term: Connective Tissue Diseases
  sharing ipd: No