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/NCT05963048</url>
    </required_header>
    <id_info>
      <org_study_id>Scleroderma</org_study_id>
      <nct_id>NCT05963048</nct_id>
    </id_info>
    <brief_title>Rituxmab Versus IL-6 in Treating ILD</brief_title>
    <official_title>Comparative Study About Effect of Rituximab Versus IL-6 Inhibitor in Induction of Remission in Active ILD in Scleroderma Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assiut University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assiut University</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        All SSc patients should know if they have been diagnosed with interstitial lung disease, or&#xD;
        pulmonary hypertension and keep results from his/her last pulmonary function test, chest&#xD;
        imaging, echocardiogram and stress test&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All SSc patients should know if they have been diagnosed with interstitial lung disease, or&#xD;
        pulmonary hypertension and keep results from his/her last pulmonary function test, chest&#xD;
        imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive&#xD;
        shortness of breath is the most frequently presentation going to ER pulmonary unit first. It&#xD;
        should be considered in case of persistent dry cough or dyspnea, which should be looked for&#xD;
        in any patient with SSc. an etiological assessment must be conducted in order not to&#xD;
        mistakenly attribute ILD to the SSc.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 1, 2021</start_date>
    <completion_date type="Actual">June 1, 2023</completion_date>
    <primary_completion_date type="Actual">December 30, 2022</primary_completion_date>
    <phase>Phase 2/Phase 3</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>
      <masking_description>participant and outcome assrssor</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>forced vital capacity</measure>
      <time_frame>6 months</time_frame>
      <description>pulmonary function test</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CT chest</measure>
      <time_frame>1 year</time_frame>
      <description>imaging</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>modified rodnan skin score</measure>
      <time_frame>6 months</time_frame>
      <description>skin score</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">60</enrollment>
    <condition>Interstitial Lung Disease</condition>
    <condition>Scleroderma</condition>
    <arm_group>
      <arm_group_label>Rituxmab</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year</description>
    </arm_group>
    <arm_group>
      <arm_group_label>IL-6 inhibitor</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>6 mg/kg IV infusion every month not exceed 600 mg for 1 year</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Rituximab</intervention_name>
      <description>IV infusion 1000 mg</description>
      <arm_group_label>Rituxmab</arm_group_label>
      <other_name>Rituxan</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>IL6 inhibitor</intervention_name>
      <description>6 mg/kg I V infusion monthly</description>
      <arm_group_label>IL-6 inhibitor</arm_group_label>
      <other_name>Actemra</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  active ILD scleroderma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  abnormal liver enzymes renal impairment neutropenia &lt;1000 cells/mm3 thrombocytopenia &lt;&#xD;
               50,000 cells/mm3&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Manal Hassanien, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assiut University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Manal Hassanien</name>
        <address>
          <city>Assiut</city>
          <state>Yes</state>
          <zip>7111</zip>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>December 25, 2022</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Assiut University</investigator_affiliation>
      <investigator_full_name>Manal Hassanien</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Diseases</mesh_term>
      <mesh_term>Lung Diseases, Interstitial</mesh_term>
      <mesh_term>Scleroderma, Systemic</mesh_term>
      <mesh_term>Scleroderma, Diffuse</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rituximab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>after finishing</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>one year</ipd_time_frame>
      <ipd_access_criteria>after finishing the study</ipd_access_criteria>
    </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/NCT05963048
  org study id: Scleroderma
  nct id: NCT05963048
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  All SSc patients should know if they have been diagnosed with interstitial lung disease, or
        pulmonary hypertension and keep results from his/her last pulmonary function test, chest
        imaging, echocardiogram and stress test
  All SSc patients should know if they have been diagnosed with interstitial lung disease, or
        pulmonary hypertension and keep results from his/her last pulmonary function test, chest
        imaging, echocardiogram and stress test Diffuse infiltrative lung disease (ILD): progressive
        shortness of breath is the most frequently presentation going to ER pulmonary unit first. It
        should be considered in case of persistent dry cough or dyspnea, which should be looked for
        in any patient with SSc. an etiological assessment must be conducted in order not to
        mistakenly attribute ILD to the SSc.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: participant and outcome assrssor
  measure: forced vital capacity
  time frame: 6 months
  description: pulmonary function test
  measure: CT chest
  time frame: 1 year
  description: imaging
  measure: modified rodnan skin score
  time frame: 6 months
  description: skin score
  arm group label: Rituxmab
  arm group type: Experimental
  description: 1000 mg Rituxmab IV infusion at 1st day then after 15 weeks then after 6 months for 1 year
  arm group label: IL-6 inhibitor
  arm group type: Experimental
  description: 6 mg/kg IV infusion every month not exceed 600 mg for 1 year
  intervention type: Drug
  intervention name: Rituximab
  description: IV infusion 1000 mg
  arm group label: Rituxmab
  other name: Rituxan
  intervention type: Drug
  intervention name: IL6 inhibitor
  description: 6 mg/kg I V infusion monthly
  arm group label: IL-6 inhibitor
  other name: Actemra
  criteria: 
  gender: All
  minimum age: 20 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Manal Hassanien, MD
  role: Principal Investigator
  affiliation: Assiut University
  facility: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Assiut University
  investigator full name: Manal Hassanien
  investigator title: Associate Professor
  mesh term: Lung Diseases
  mesh term: Lung Diseases, Interstitial
  mesh term: Scleroderma, Systemic
  mesh term: Scleroderma, Diffuse
  mesh term: Rituximab
  sharing ipd: Yes
  ipd description: after finishing
  ipd info type: Study Protocol
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: one year
  ipd access criteria: after finishing the study