<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/NCT03769168</url>
  </required_header>
  <id_info>
    <org_study_id>CAIN457F2304E1</org_study_id>
    <secondary_id>2018-002521-30</secondary_id>
    <nct_id>NCT03769168</nct_id>
  </id_info>
  <brief_title>An Extension Study of Subcutaneous Secukinumab in Patients With Juvenile Psoriatic Arthritis (JPsA) and Enthesitis Related Arthritis (ERA)</brief_title>
  <official_title>An Extension Study of Subcutaneous Secukinumab to Evaluate the Long-term Efficacy, Safety and Tolerability up to 4 Years in Patients With Juvenile Idiopathic Arthritis Subtypes of Juvenile Psoriatic Arthritis and Enthesitis Related Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Optional open label, roll over extension study to investigate the efficacy and safety of&#xD;
      secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic&#xD;
      Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      NOTE: Detailed Description : data not entered&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 7, 2019</start_date>
  <completion_date type="Anticipated">November 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">October 3, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Open-label</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with JIA ACR30 response</measure>
    <time_frame>308 weeks</time_frame>
    <description>JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are:&#xD;
Physician global assessment of overall disease activity&#xD;
Parent's or patients' global assessment of patient's overall well-being&#xD;
Functional ability (CHAQ: Childhood Health Assessment Questionnaire)&#xD;
Number of joints with active arthritis&#xD;
Number of joint with limited range of motion&#xD;
Index of inflammation: C-reactive Protein (CRP)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with JIA ACR 50/70/90/100 response</measure>
    <time_frame>308 weeks</time_frame>
    <description>JIA ACR 50/70/90/100 are defined as 50%, 70%, 90% and 100% improvement from baseline respectively in a minimum of three out of six variables with no more than one variable worsening more than 50%, 70%, 90% and 100% respectively, as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR responses are:&#xD;
Physician global assessment of overall disease activity&#xD;
Parent's or patients' global assessment of patient's overall well-being&#xD;
Functional ability (CHAQ:&quot; Childhood Health Assessment Questionnaire)&#xD;
Number of joints with active arthritis&#xD;
Number of joint with limited range of motion&#xD;
Index of inflammation: C-reactive Protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with inactive disease status</measure>
    <time_frame>308 weeks</time_frame>
    <description>In order for inactive disease to be confirmed in a patient when all the following conditions are met:&#xD;
No joints with active arthritis&#xD;
No uveitis&#xD;
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA&#xD;
Physician's global assessment of disease activity score ≤ 10mm&#xD;
Duration of morning stiffness attributable to JIA lasting ≥15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)</measure>
    <time_frame>308 weeks</time_frame>
    <description>JADAS will be derived from the following assessments:&#xD;
Physician global assessment of overall disease activity&#xD;
Parent's or patients' global assessment of patient's overall well-being&#xD;
Number of joints with active arthritis&#xD;
Tender and swollen joint counts&#xD;
Index of inflammation: C-reactive Protein (CRP)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with total Enthesitis count</measure>
    <time_frame>308 weeks</time_frame>
    <description>16 joints will be assessed for tenderness on each side of the body.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with total Dactylitis count</measure>
    <time_frame>308 weeks</time_frame>
    <description>The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetics (PK) of secukinumab</measure>
    <time_frame>308 weeks</time_frame>
    <description>Concentration of secukinumab in the body</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Juvenile Psoriatic Arthritis</condition>
  <condition>Enthesitis Related Arthritis</condition>
  <arm_group>
    <arm_group_label>Group 1 - Secukinumab 75 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 - Secukinumab (AIN457) 75 mg/0.5mL</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - Secukinumab 150 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 2 - Secukinumab (AIN457) 150 mg/1.0mL</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AIN457</intervention_name>
    <description>Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.</description>
    <arm_group_label>Group 1 - Secukinumab 75 mg</arm_group_label>
    <arm_group_label>Group 2 - Secukinumab 150 mg</arm_group_label>
    <other_name>Secukinumab</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient must have participated in core study CAIN457F2304, and must have completed the&#xD;
             entire treatment period up to and including Week 104.&#xD;
&#xD;
          2. Patients must be deemed by the investigator to benefit from continued secukinumab&#xD;
             therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Plans for administration of live vaccines during the extension study period.&#xD;
&#xD;
          2. Any patient taking other concomitant biologic immunomodulating agent(s) except&#xD;
             secukinumab.&#xD;
&#xD;
          3. Any patient who is deemed not to be benefiting from the study treatment based upon&#xD;
             lack of improvement or worsening of their symptoms.&#xD;
&#xD;
        All other protocol related inclusion/exclusion criteria will apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bruxelles</city>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Freiburg</city>
        <zip>79106</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint Augustin</city>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Genova</city>
        <state>GE</state>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Napoli</city>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Krakow</city>
        <zip>31503</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ekaterinburg</city>
        <zip>620149</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Moscow</city>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Saint-Petersburg</city>
        <zip>194100</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Voronezh</city>
        <zip>394036</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Panorama</city>
        <state>Western Cape</state>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Cape Town</city>
        <zip>7925</zip>
        <country>South Africa</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Santiago de Compostela</city>
        <state>Galicia</state>
        <zip>15706</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <state>Halkali</state>
        <zip>34303</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <state>TUR</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Istanbul</city>
        <zip>34390</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>September 6, 2023</last_update_submitted>
  <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>JIA</keyword>
  <keyword>JPsA</keyword>
  <keyword>ERA</keyword>
  <keyword>Secukinumab</keyword>
  <keyword>ILAR</keyword>
  <keyword>Juvenile Psoriatic Arthritis</keyword>
  <keyword>Enthesitis Related Arthritis</keyword>
  <keyword>cain457</keyword>
  <keyword>cain457f</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Enthesopathy</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </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/NCT03769168
org study id: CAIN457F2304E1
secondary id: 2018-002521-30
nct id: NCT03769168
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Optional open label, roll over extension study to investigate the efficacy and safety of
      secukinumab treatment in Juvenile Idiopathic Arthritis (JIA) subtypes of Juvenile Psoriatic
      Arthritis (JPsA) and Enthesitis Related Arthritis (ERA).
NOTE: Detailed Description : data not entered
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
masking description: Open-label
measure: Number of participants with JIA ACR30 response
time frame: 308 weeks
description: JIA ACR 30 is defined as 30% improvement from baseline in a minimum of three out of six variables with no more than one variable worsening more than 30% as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR 30 are:
Physician global assessment of overall disease activity
Parent's or patients' global assessment of patient's overall well-being
Functional ability (CHAQ: Childhood Health Assessment Questionnaire)
Number of joints with active arthritis
Number of joint with limited range of motion
Index of inflammation: C-reactive Protein (CRP)
measure: Number of participants with JIA ACR 50/70/90/100 response
time frame: 308 weeks
description: JIA ACR 50/70/90/100 are defined as 50%, 70%, 90% and 100% improvement from baseline respectively in a minimum of three out of six variables with no more than one variable worsening more than 50%, 70%, 90% and 100% respectively, as defined in the ACR criteria. The six variables assessed in order to calculate JIA ACR responses are:
Physician global assessment of overall disease activity
Parent's or patients' global assessment of patient's overall well-being
Functional ability (CHAQ:" Childhood Health Assessment Questionnaire)
Number of joints with active arthritis
Number of joint with limited range of motion
Index of inflammation: C-reactive Protein (CRP)
measure: Number of participants with inactive disease status
time frame: 308 weeks
description: In order for inactive disease to be confirmed in a patient when all the following conditions are met:
No joints with active arthritis
No uveitis
CRP value within normal limits for the laboratory where tested or, if elevated, not attributable to JIA
Physician's global assessment of disease activity score ≤ 10mm
Duration of morning stiffness attributable to JIA lasting ≥15 minutes.
measure: Number of participants with Juvenile Arthritis Disease Activity Score (JADAS)
time frame: 308 weeks
description: JADAS will be derived from the following assessments:
Physician global assessment of overall disease activity
Parent's or patients' global assessment of patient's overall well-being
Number of joints with active arthritis
Tender and swollen joint counts
Index of inflammation: C-reactive Protein (CRP)
measure: Number of participants with total Enthesitis count
time frame: 308 weeks
description: 16 joints will be assessed for tenderness on each side of the body.
measure: Number of participants with total Dactylitis count
time frame: 308 weeks
description: The dactylitis count is the number of fingers and toes presenting with swelling and inflammation.
measure: Pharmacokinetics (PK) of secukinumab
time frame: 308 weeks
description: Concentration of secukinumab in the body
arm group label: Group 1 - Secukinumab 75 mg
arm group type: Experimental
description: Group 1 - Secukinumab (AIN457) 75 mg/0.5mL
arm group label: Group 2 - Secukinumab 150 mg
arm group type: Experimental
description: Group 2 - Secukinumab (AIN457) 150 mg/1.0mL
intervention type: Drug
intervention name: AIN457
description: Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.
arm group label: Group 1 - Secukinumab 75 mg
arm group label: Group 2 - Secukinumab 150 mg
other name: Secukinumab
criteria: 
gender: All
minimum age: 2 Years
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
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country: Belgium
country: Germany
country: Italy
country: Poland
country: Russian Federation
country: South Africa
country: Spain
country: Turkey
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Enthesopathy
mesh term: Arthritis, Juvenile
sharing ipd: Yes
ipd description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com