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/NCT05974683</url>
    </required_header>
    <id_info>
      <org_study_id>IgG4 re-elevation treatment</org_study_id>
      <nct_id>NCT05974683</nct_id>
    </id_info>
    <brief_title>Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period</brief_title>
    <official_title>A Study of Two Different Treatment Strategies in IgG4-related Disease Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period: a Randomized Double Blind Placebo Controlled Multicenter Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beijing Friendship Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tongji Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <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 has been designed as a 52-week, randomized double blind placebo controlled&#xD;
        multicenter clinical trial. The study aims to compare the efficacy and safety of two&#xD;
        treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during&#xD;
        maintenance remission period: basic maintenance treatment group (continue use of basic&#xD;
        maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate&#xD;
        mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4&#xD;
        level during maintenance remission period are to be enrolled in this study after screening&#xD;
        period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance&#xD;
        treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and&#xD;
        enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic&#xD;
        maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the&#xD;
        follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD&#xD;
        responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate&#xD;
        between two groups at 52 weeks. Meanwhile, this study will also explore and study different&#xD;
        biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic&#xD;
        factors of IgG4-RD.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The difference of relapse rate of IgG4-RD between two groups in week 52.</measure>
      <time_frame>52 weeks</time_frame>
      <description>The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The difference of relapse rate of IgG4-RD between two groups in the week 12.</measure>
      <time_frame>12 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference of relapse rate of IgG4-RD between two groups in the week 24</measure>
      <time_frame>24 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The difference of relapse rate of IgG4-RD between two groups in the week 36.</measure>
      <time_frame>36 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The time and duration of relapse</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of IgG4-RD Responder Index at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of serum IgG level at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of serum IgG4 level at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of erythrocyte sedimentation rate at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of serum C-reactive protein level at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse effect events</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The changes of Physician Global Assessment score at week 52</measure>
      <time_frame>52 weeks</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">108</enrollment>
    <condition>Autoimmune Diseases</condition>
    <arm_group>
      <arm_group_label>Basic Maintenance Treatment</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Enhancement Treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>placebo</intervention_name>
      <description>Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52</description>
      <arm_group_label>Basic Maintenance Treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>mycophenolate mofetil</intervention_name>
      <description>Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52</description>
      <arm_group_label>Enhancement Treatment</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Fulfillment of the 2019 American College of Rheumatology/European League against&#xD;
               Rheumatology (ACR/EULAR) IgG4-related disease classification criteria or the 2020&#xD;
               revised comprehensive diagnostic (RCD) criteria for IgG4-RD.&#xD;
  &#xD;
            -  2. Age between 18 and 70 years.&#xD;
  &#xD;
            -  3. Elevation of baseline serum IgG4 level (&gt;1400mg/L).&#xD;
  &#xD;
            -  4. Major organ involvement, including but not limited to autoimmune pancreatitis,&#xD;
               retroperitoneal fibrosis, sclerosing cholangitis, IgG4-related Castleman disease, and&#xD;
               involvement of the lungs, kidney, nasal sinus, and central nervous system.&#xD;
  &#xD;
            -  5. Re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4 level during&#xD;
               maintenance remission period, with no evidence of relapse.&#xD;
  &#xD;
            -  6. Written informed consent signed.&#xD;
  &#xD;
            -  7. Agreed to take highly effective contraceptive procedures from signing of informed&#xD;
               consent till 6 months after the end of last visit.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Patients with an IgG4-RD Responder Index ≥ 2 points of any organ system.&#xD;
  &#xD;
            -  2. IgG4-RD patients without major organ involvement.&#xD;
  &#xD;
            -  3. Patients with severe or active infections, including but not limited to HIV, HCV,&#xD;
               HBV, TB.&#xD;
  &#xD;
            -  4. Patients with malignancies or a history of malignancies within 5 years, except:&#xD;
  &#xD;
                 1. Patients with adenocarcinoma in situ (AIS) of the cervix who have received&#xD;
                    curative treatment for at least 12 months before screening.&#xD;
  &#xD;
                 2. Patients with cutaneous basal or squamous cell carcinoma who have received&#xD;
                    curative treatment.&#xD;
  &#xD;
                 3. Patients with prostate cancer, who have received radical prostatectomy or&#xD;
                    definitive radiotherapy for over 3 years, with no sign of relapse or ongoing&#xD;
                    treatment&#xD;
  &#xD;
            -  5. Patients with immunodeficiency diseases.&#xD;
  &#xD;
            -  6. Patients with severe cardiovascular, respiratory, endocrine, gastrointestinal,&#xD;
               hematological, neuropsychological, or constitutional comorbidities; or at risk of&#xD;
               unacceptable complications, or having confounding factors in safety and explanation of&#xD;
               results according to the evaluations from investigators.&#xD;
  &#xD;
            -  7. Patients with other rheumatic diseases, including but not limited to rheumatoid&#xD;
               arthritis, systemic lupus erythematosus, systemic vasculitis, sarcoidosis; or other&#xD;
               mimickers of IgG4-RD, including but not limited to Rosai-Dorfman disease, Castleman&#xD;
               disease.&#xD;
  &#xD;
            -  8. Participating in any other clinical trials with drug interventions.&#xD;
  &#xD;
            -  9. A history of alcohol or drug abuse, possibly harming patient's safety, compliance,&#xD;
               or evaluation of study's safety or other necessary aspects according to the&#xD;
               evaluations from investigators.&#xD;
  &#xD;
            -  10. Women during pregnancy, lactation, or planning of pregnancy within 6 months of the&#xD;
               last visit of the study.&#xD;
  &#xD;
            -  11. Meeting any of the following blood test finding on screening:&#xD;
  &#xD;
                 1. Hemoglobin level &lt; 7.5g/dL.&#xD;
  &#xD;
                 2. neutrophil count &lt; 1.0×10^9/L.&#xD;
  &#xD;
                 3. Platelet count &lt; 100×10^9/L.&#xD;
  &#xD;
                 4. Alanine aminotransferase (ALT) &gt; 2 × upper limit number (ULN).&#xD;
  &#xD;
                 5. Aspartate aminotransferase (AST) &gt; 2 × ULN.&#xD;
  &#xD;
                 6. Total Bilirubin (TBil) &gt; 2 × ULN.&#xD;
  &#xD;
                 7. Estimated glomerular filtration rate (eGFR) &lt; 30ml/(min·1.73m^2), calculated&#xD;
                    using the Modification of Diet in Renal Disease (MDRD) study equation by the&#xD;
                    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Wen Zhang, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jiaxin Zhou, MD</last_name>
      <phone>86-10-69155647</phone>
      <email>pumczhou@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Linyi Peng, MD</last_name>
      <phone>86-10-69155647</phone>
      <email>pumczhou@sina.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Jiaxin Zhou, ND</last_name>
        <phone>86-10-69155647</phone>
        <email>pumczhou@sina.com</email>
      </contact>
      <contact_backup>
        <last_name>Linyi Peng, MD</last_name>
        <phone>86-10-69155647</phone>
        <email>pumczhou@sina.com</email>
      </contact_backup>
      <investigator>
        <last_name>Wen Zhang, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Zhang W, Stone J H. Management of IgG4-related disease[J]. The Lancet Rheumatology, 2019, 1(1): e55-e65.</citation>
    </reference>
    <reference>
      <citation>Wallace ZS, Naden RP, Chari S, Choi HK, Della-Torre E, Dicaire JF, Hart PA, Inoue D, Kawano M, Khosroshahi A, Lanzillotta M, Okazaki K, Perugino CA, Sharma A, Saeki T, Schleinitz N, Takahashi N, Umehara H, Zen Y, Stone JH; Members of the ACR/EULAR IgG4-RD Classification Criteria Working Group. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 2020 Jan;79(1):77-87. doi: 10.1136/annrheumdis-2019-216561. Epub 2019 Dec 3.</citation>
      <PMID>31796497</PMID>
    </reference>
    <reference>
      <citation>Lin W, Lu S, Chen H, Wu Q, Fei Y, Li M, Zhang X, Tian X, Zheng W, Leng X, Xu D, Wang Q, Shen M, Wang L, Li J, Wu D, Zhao L, Wu C, Yang Y, Peng L, Zhou J, Wang Y, Sha Y, Huang X, Jiao Y, Zeng X, Shi Q, Li P, Zhang S, Hu C, Deng C, Li Y, Zhang S, Liu J, Su J, Hou Y, Jiang Y, You X, Zhang H, Yan L, Zhang W, Zhao Y, Zeng X, Zhang F, Lipsky PE. Clinical characteristics of immunoglobulin G4-related disease: a prospective study of 118 Chinese patients. Rheumatology (Oxford). 2015 Nov;54(11):1982-90. doi: 10.1093/rheumatology/kev203. Epub 2015 Jun 22.</citation>
      <PMID>26106212</PMID>
    </reference>
    <reference>
      <citation>Umehara H, Okazaki K, Kawa S, Takahashi H, Goto H, Matsui S, Ishizaka N, Akamizu T, Sato Y, Kawano M; Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan.. The 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD. Mod Rheumatol. 2021 May;31(3):529-533. doi: 10.1080/14397595.2020.1859710. Epub 2021 Jan 28.</citation>
      <PMID>33274670</PMID>
    </reference>
    <reference>
      <citation>Khosroshahi A, Wallace ZS, Crowe JL, Akamizu T, Azumi A, Carruthers MN, Chari ST, Della-Torre E, Frulloni L, Goto H, Hart PA, Kamisawa T, Kawa S, Kawano M, Kim MH, Kodama Y, Kubota K, Lerch MM, Lohr M, Masaki Y, Matsui S, Mimori T, Nakamura S, Nakazawa T, Ohara H, Okazaki K, Ryu JH, Saeki T, Schleinitz N, Shimatsu A, Shimosegawa T, Takahashi H, Takahira M, Tanaka A, Topazian M, Umehara H, Webster GJ, Witzig TE, Yamamoto M, Zhang W, Chiba T, Stone JH; Second International Symposium on IgG4-Related Disease. International Consensus Guidance Statement on the Management and Treatment of IgG4-Related Disease. Arthritis Rheumatol. 2015 Jul;67(7):1688-99. doi: 10.1002/art.39132. No abstract available.</citation>
      <PMID>25809420</PMID>
    </reference>
    <reference>
      <citation>Yunyun F, Yu P, Panpan Z, Xia Z, Linyi P, Jiaxin Z, Li Z, Shangzhu Z, Jinjing L, Di W, Yamin L, Xiaowei L, Huadan X, Xuan Z, Xiaofeng Z, Fengchun Z, Yan Z, Wen Z. Efficacy and safety of low dose Mycophenolate mofetil treatment for immunoglobulin G4-related disease: a randomized clinical trial. Rheumatology (Oxford). 2019 Jan 1;58(1):52-60. doi: 10.1093/rheumatology/key227.</citation>
      <PMID>30124952</PMID>
    </reference>
    <reference>
      <citation>Peng Y, Li JQ, Zhang PP, Zhang X, Peng LY, Chen H, Zhou JX, Zhang SZ, Yang HX, Liu JJ, Guo HF, Li J, Zhang X, Zhao Y, Zeng XF, Zhang FC, Fei YY, Zhang W. Clinical outcomes and predictive relapse factors of IgG4-related disease following treatment: a long-term cohort study. J Intern Med. 2019 Nov;286(5):542-552. doi: 10.1111/joim.12942. Epub 2019 Jun 17.</citation>
      <PMID>31121062</PMID>
    </reference>
    <reference>
      <citation>Liu Z, Peng Y, Li J, Lu H, Peng L, Zhou J, Zhou S, Huang C, Wang M, Zhu L, Chen H, Wang L, Fei Y, Zhao Y, Zeng X, Zhang W. Prediction of new organ onset in recurrent immunoglobulin G4-related disease during 10 years of follow-up. J Intern Med. 2022 Jul;292(1):91-102. doi: 10.1111/joim.13477. Epub 2022 Apr 13.</citation>
      <PMID>35419810</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Wen Zhang</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Immunoglobulin G4-Related Disease</keyword>
    <keyword>Drug therapy</keyword>
    <keyword>Relapse</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autoimmune Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Mycophenolic Acid</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT05974683
  org study id: IgG4 re-elevation treatment
  nct id: NCT05974683
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study has been designed as a 52-week, randomized double blind placebo controlled
        multicenter clinical trial. The study aims to compare the efficacy and safety of two
        treatment strategies in IgG4-RD patients with re-elevation of serum IgG4 level during
        maintenance remission period: basic maintenance treatment group (continue use of basic
        maintenance treatment of IgG4-RD) and enhanced treatment group (use low dose mycophenolate
        mofetil as an add-on therapy of basic maintenance treatment of IgG4-RD).
  108 IgG4-RD patients with re-elevation of serum IgG4 level to ≥30% of baseline serum IgG4
        level during maintenance remission period are to be enrolled in this study after screening
        period, and then double blind randomly in an 1:1 ratio into two groups: basic maintenance
        treatment group (continue use of basic maintenance treatment of IgG4-RD plus placebo) and
        enhanced treatment group (use low dose mycophenolate mofetil as an add-on therapy of basic
        maintenance treatment of IgG4-RD). The follow-up period will be 52 weeks. During the
        follow-up period, clinical evaluations, laboratory tests, image examinations and IgG4-RD
        responder index (RI) will be recorded. The primary endpoint is the difference of relapse rate
        between two groups at 52 weeks. Meanwhile, this study will also explore and study different
        biomarkers in IgG4-RD patients, to better understand the mechanisms, as well as prognostic
        factors of IgG4-RD.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: The difference of relapse rate of IgG4-RD between two groups in week 52.
  time frame: 52 weeks
  description: The primary endpoint is the difference of relapse rate between two groups at 52 weeks. The definition of relapse: elevation of IgG4-RD Responder Index ≥ 2 points; new organ involvement or recurrence, with or without elevation of serum IgG4 levels.
  measure: The difference of relapse rate of IgG4-RD between two groups in the week 12.
  time frame: 12 weeks
  measure: The difference of relapse rate of IgG4-RD between two groups in the week 24
  time frame: 24 weeks
  measure: The difference of relapse rate of IgG4-RD between two groups in the week 36.
  time frame: 36 weeks
  measure: The time and duration of relapse
  time frame: 52 weeks
  measure: The changes of IgG4-RD Responder Index at week 52
  time frame: 52 weeks
  measure: The changes of serum IgG level at week 52
  time frame: 52 weeks
  measure: The changes of serum IgG4 level at week 52
  time frame: 52 weeks
  measure: The changes of erythrocyte sedimentation rate at week 52
  time frame: 52 weeks
  measure: The changes of serum C-reactive protein level at week 52
  time frame: 52 weeks
  measure: Adverse effect events
  time frame: 52 weeks
  measure: The changes of Physician Global Assessment score at week 52
  time frame: 52 weeks
  arm group label: Basic Maintenance Treatment
  arm group type: Placebo Comparator
  description: Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
  arm group label: Enhancement Treatment
  arm group type: Active Comparator
  description: Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
  intervention type: Drug
  intervention name: placebo
  description: Continue use of current basic maintenance treatment of IgG4-RD plus placebo, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
  arm group label: Basic Maintenance Treatment
  intervention type: Drug
  intervention name: mycophenolate mofetil
  description: Use low dose mycophenolate mofetil (0.5g per day) as an add-on therapy of current basic maintenance treatment of IgG4-RD, Follow-up intervals: week 4, week 12, week 24, week 36, week 52
  arm group label: Enhancement Treatment
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Wen Zhang, MD
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Jiaxin Zhou, MD
  phone: 86-10-69155647
  email: pumczhou@sina.com
  last name: Linyi Peng, MD
  phone: 86-10-69155647
  email: pumczhou@sina.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Zhang W, Stone J H. Management of IgG4-related disease[J]. The Lancet Rheumatology, 2019, 1(1): e55-e65.
  citation: Wallace ZS, Naden RP, Chari S, Choi HK, Della-Torre E, Dicaire JF, Hart PA, Inoue D, Kawano M, Khosroshahi A, Lanzillotta M, Okazaki K, Perugino CA, Sharma A, Saeki T, Schleinitz N, Takahashi N, Umehara H, Zen Y, Stone JH; Members of the ACR/EULAR IgG4-RD Classification Criteria Working Group. The 2019 American College of Rheumatology/European League Against Rheumatism classification criteria for IgG4-related disease. Ann Rheum Dis. 2020 Jan;79(1):77-87. doi: 10.1136/annrheumdis-2019-216561. Epub 2019 Dec 3.
  PMID: 31796497
  citation: Lin W, Lu S, Chen H, Wu Q, Fei Y, Li M, Zhang X, Tian X, Zheng W, Leng X, Xu D, Wang Q, Shen M, Wang L, Li J, Wu D, Zhao L, Wu C, Yang Y, Peng L, Zhou J, Wang Y, Sha Y, Huang X, Jiao Y, Zeng X, Shi Q, Li P, Zhang S, Hu C, Deng C, Li Y, Zhang S, Liu J, Su J, Hou Y, Jiang Y, You X, Zhang H, Yan L, Zhang W, Zhao Y, Zeng X, Zhang F, Lipsky PE. Clinical characteristics of immunoglobulin G4-related disease: a prospective study of 118 Chinese patients. Rheumatology (Oxford). 2015 Nov;54(11):1982-90. doi: 10.1093/rheumatology/kev203. Epub 2015 Jun 22.
  PMID: 26106212
  citation: Umehara H, Okazaki K, Kawa S, Takahashi H, Goto H, Matsui S, Ishizaka N, Akamizu T, Sato Y, Kawano M; Research Program for Intractable Disease by the Ministry of Health, Labor and Welfare (MHLW) Japan.. The 2020 revised comprehensive diagnostic (RCD) criteria for IgG4-RD. Mod Rheumatol. 2021 May;31(3):529-533. doi: 10.1080/14397595.2020.1859710. Epub 2021 Jan 28.
  PMID: 33274670
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  PMID: 35419810
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Wen Zhang
  investigator title: Professor
  mesh term: Autoimmune Diseases
  mesh term: Mycophenolic Acid
  sharing ipd: Yes