<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/NCT03793660</url>
  </required_header>
  <id_info>
    <org_study_id>DAC-004-LITAR</org_study_id>
    <nct_id>NCT03793660</nct_id>
  </id_info>
  <brief_title>Biologic National Registry</brief_title>
  <acronym>BINAR</acronym>
  <official_title>Safety and Efficacy of Biotherapy in Rheumatoid Aarthritis and Spondyloarthritis. A Clinical Multicentric Study: Biologic National Registry (BINAR)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dacima Consulting</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ligue Tunisienne Anti Rhumatismale</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Dacima Consulting</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>
      BINAR is an open and multicentric Tunisian national registry performed by nearly 100&#xD;
      rheumatologists&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical&#xD;
      study performed in rheumatology consultations, of both public and liberal sectors. Eligible&#xD;
      patients are recruited by successive inclusions until the end of the recruitment period, set&#xD;
      at one year. A Scientific Committee validates the scientific writing, a Steering Committee&#xD;
      supervises the clinical operations of the project and a Data Review Committee supervises the&#xD;
      management of the data and carries out all the missions of audit and control of validity of&#xD;
      the collected data, as well as the planning of statistical analysis.&#xD;
&#xD;
      Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture&#xD;
      platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug&#xD;
      Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health&#xD;
      Insurance Portability and Accountability Act), and the ICH standards (International&#xD;
      Conference on Harmonisation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2018</start_date>
  <completion_date type="Actual">June 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>24 Months</target_duration>
  <primary_outcome>
    <measure>Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy</measure>
    <time_frame>Up to two years of follow-up</time_frame>
    <description>Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] : occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of Rheumatoid Arthritis Activity</measure>
    <time_frame>At baseline and at two years follow-up</time_frame>
    <description>Number of patients with disease Activity Score (DAS) &lt; 2.6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Assessment Questionnaire</measure>
    <time_frame>At baseline</time_frame>
    <description>HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Spondylitis Fonctional Activity</measure>
    <time_frame>At baseline and at two years follow-up</time_frame>
    <description>Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Spondylitis Disease Activity</measure>
    <time_frame>At baseline and at two years follow-up</time_frame>
    <description>Bath Ankylosing Spondylitis Disease Activity Index measurement (BASDAI) : (range score 0-10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Spondylitis Activity</measure>
    <time_frame>At baseline and at two years follow-up</time_frame>
    <description>Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) &lt; 2.1</description>
  </secondary_outcome>
  <enrollment type="Actual">439</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <condition>Spondylitis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients treated with biologic for rheumatoid arthritis or spondylitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Patient followed for rheumatoid arthritis according to ACR EULAR criteria or&#xD;
             spondylitis including all disorders (axial, peripheral, enthesitis).&#xD;
&#xD;
          -  Patient on biological treatment at the time of inclusion&#xD;
&#xD;
          -  First biological treatment initiated ≤ 2 years&#xD;
&#xD;
          -  Informed consent, read and signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evolutionary neoplasia at the time of inclusion&#xD;
&#xD;
          -  Other associated systemic diseases, except Sjögren's Syndrome&#xD;
&#xD;
          -  Consent not obtained&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Samir Kochbati, MD</last_name>
    <role>Study Chair</role>
    <affiliation>LITAR : Ligue Tunisienne Anti Rhumatismale</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kawther Ben Abdelghani, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>LITAR : Ligue Tunisienne Anti Rhumatismale</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rheumatology Department - Habib Thameur</name>
      <address>
        <city>Ben Arous</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - HMPIT</name>
      <address>
        <city>Ben Arous</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Tahar Sfar</name>
      <address>
        <city>Mahdia</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Institut Mohamed Kassab d'Orthopédie</name>
      <address>
        <city>Manouba</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Fattouma Bourguiba</name>
      <address>
        <city>Monastir</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Hédi Chaker</name>
      <address>
        <city>Sfax</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Farhat Hached</name>
      <address>
        <city>Sousse</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Charles Nicolle</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - La Rabta</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rheumatology Department - Mongi Slim</name>
      <address>
        <city>Tunis</city>
        <country>Tunisia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Tunisia</country>
  </location_countries>
  <link>
    <url>https://www.facebook.com/groups/1611044669000801/about/</url>
    <description>Social Media Group of the Project</description>
  </link>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>August 19, 2022</last_update_submitted>
  <last_update_submitted_qc>August 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biologic</keyword>
  <keyword>Safety</keyword>
  <keyword>LITAR</keyword>
  <keyword>DACIMA</keyword>
  <keyword>Tunisia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03793660
org study id: DAC-004-LITAR
nct id: NCT03793660
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
BINAR is an open and multicentric Tunisian national registry performed by nearly 100
      rheumatologists
BINAR is a Tunisian, descriptive, non-interventional, multicenter and prospective clinical
      study performed in rheumatology consultations, of both public and liberal sectors. Eligible
      patients are recruited by successive inclusions until the end of the recruitment period, set
      at one year. A Scientific Committee validates the scientific writing, a Steering Committee
      supervises the clinical operations of the project and a Data Review Committee supervises the
      management of the data and carries out all the missions of audit and control of validity of
      the collected data, as well as the planning of statistical analysis.

      Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture
      platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug
      Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health
      Insurance Portability and Accountability Act), and the ICH standards (International
      Conference on Harmonisation).
observational model: Cohort
time perspective: Prospective
measure: Safety assessment of biotherapy - Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]: Occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
time frame: Up to two years of follow-up
description: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] : occurrence of infection or tuberculosis or death or neoplasia or any other treatment-related side effect of biotherapy
measure: Assessment of Rheumatoid Arthritis Activity
time frame: At baseline and at two years follow-up
description: Number of patients with disease Activity Score (DAS) < 2.6
measure: Health Assessment Questionnaire
time frame: At baseline
description: HAQ assessment for Rheumatoid Arthritis patients (range score 0-3)
measure: Assessment of Spondylitis Fonctional Activity
time frame: At baseline and at two years follow-up
description: Bath Ankylosing Spondylitis Fonctional Index measurement (BASFI) : (range score 0-10)
measure: Assessment of Spondylitis Disease Activity
time frame: At baseline and at two years follow-up
description: Bath Ankylosing Spondylitis Disease Activity Index measurement (BASDAI) : (range score 0-10)
measure: Assessment of Spondylitis Activity
time frame: At baseline and at two years follow-up
description: Number of patients with Ankylosing Spondylitis Disease Activity Score (ASDAS) < 2.1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samir Kochbati, MD
role: Study Chair
affiliation: LITAR : Ligue Tunisienne Anti Rhumatismale
last name: Kawther Ben Abdelghani, MD
role: Principal Investigator
affiliation: LITAR : Ligue Tunisienne Anti Rhumatismale
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Tunisia
url: https://www.facebook.com/groups/1611044669000801/about/
description: Social Media Group of the Project
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Arthritis, Rheumatoid
sharing ipd: Undecided