<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/NCT03265132</url>
  </required_header>
  <id_info>
    <org_study_id>Sobi.ANAKIN-301</org_study_id>
    <nct_id>NCT03265132</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Still's Disease (SJIA and AOSD)</brief_title>
  <acronym>anaSTILLs</acronym>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Efficacy and Safety Study of 2 Dose Levels of Subcutaneous Anakinra (Kineret®) in Patients With Still's Disease (SJIA and AOSD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Swedish Orphan Biovitrum</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Swedish Orphan Biovitrum</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to demonstrate the efficacy and to evaluate the safety,&#xD;
      pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's&#xD;
      disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset&#xD;
      Still's disease).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study consists of a 12-week, randomized, double-blind, placebo controlled period with two&#xD;
      dose levels of anakinra and a 4-week safety follow-up after last dose of investigational&#xD;
      medicinal product (IMP). The primary endpoint will be evaluated at Week 2. Sustained efficacy&#xD;
      and time to study drug discontinuation will be evaluated during the full study period.&#xD;
&#xD;
      A screening visit is optional and may be done to identify patients that could be suitable for&#xD;
      the study. During the study 6 visits and 2 telephone contacts are scheduled i.e., Day 1&#xD;
      (baseline visit), Day 4Tel, Week 1, Week 2, Week 4, Week 8, Week 12 and Week 16Tel (End of&#xD;
      Study).&#xD;
&#xD;
      Patients will be randomly assigned to study drug, after they meet all of the inclusion&#xD;
      criteria and none of the exclusion criteria. Patients will receive treatment for 12 weeks,&#xD;
      either anakinra or placebo. Patients will be randomized to anakinra in a dose of either 2 or&#xD;
      4 mg/kg/day, with a maximum dose of 100 or 200 mg once daily, respectively. Patients will be&#xD;
      randomized to placebo with corresponding volumes for each of the two anakinra dose levels.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Meeting enrolment target (81 pat) will not be feasible within reasonable time.&#xD;
  </why_stopped>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">May 23, 2019</completion_date>
  <primary_completion_date type="Actual">February 13, 2019</primary_completion_date>
  <phase>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>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.</measure>
    <time_frame>Week 2</time_frame>
    <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline. (ACR: American College of Rheumatology)&#xD;
Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).&#xD;
Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).&#xD;
Number of joints with active arthritis.&#xD;
Number of joints with limitation of motion.&#xD;
Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).&#xD;
C-Reactive Protein (CRP) (mg/L).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.</measure>
    <time_frame>Week 1</time_frame>
    <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.</measure>
    <time_frame>Week 1</time_frame>
    <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.</measure>
    <time_frame>Week 1</time_frame>
    <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.</measure>
    <time_frame>Week 1</time_frame>
    <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.</measure>
    <time_frame>Week 2</time_frame>
    <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.</measure>
    <time_frame>Week 2</time_frame>
    <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.</measure>
    <time_frame>Week 2</time_frame>
    <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in Physician Global Assessment of Disease Activity.</measure>
    <time_frame>Week 2</time_frame>
    <description>Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.</measure>
    <time_frame>Week 2</time_frame>
    <description>Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in Number of Joints With Active Arthritis.</measure>
    <time_frame>Week 2</time_frame>
    <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in Number of Joints With Limitation of Motion.</measure>
    <time_frame>Week 2</time_frame>
    <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).</measure>
    <time_frame>Week 2</time_frame>
    <description>Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Responders in CRP (mg/L).</measure>
    <time_frame>Week 2</time_frame>
    <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.</measure>
    <time_frame>Week 2</time_frame>
    <description>Proportion of patients with absence of fever during the 7 days preceding Week 2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.</measure>
    <time_frame>Week 1</time_frame>
    <description>Absence of fever during the 24 hours preceding week 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.</measure>
    <time_frame>Day 1 and Week 1</time_frame>
    <description>Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.</measure>
    <time_frame>Day 1 and Week 1</time_frame>
    <description>Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CRP.</measure>
    <time_frame>Day 1 and Week 1</time_frame>
    <description>Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.</measure>
    <time_frame>Week 12</time_frame>
    <description>Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.</measure>
    <time_frame>Week 2, Week 4, Week 8 and Week 12</time_frame>
    <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Absence of Rash.</measure>
    <time_frame>Week 2</time_frame>
    <description>Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in CRP.</measure>
    <time_frame>Week 2</time_frame>
    <description>Change from baseline in CRP. Results at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.</measure>
    <time_frame>Week 2</time_frame>
    <description>Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Platelet Count.</measure>
    <time_frame>Week 2</time_frame>
    <description>Change from baseline in platelet count. Results at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Ferritin.</measure>
    <time_frame>Week 2</time_frame>
    <description>Change from baseline in ferritin. Results at Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.</measure>
    <time_frame>Week 2</time_frame>
    <description>Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Study Drug Discontinuation for Any Reason.</measure>
    <time_frame>From Day 1 to Week12</time_frame>
    <description>Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.</measure>
    <time_frame>From Day 1 to Week12</time_frame>
    <description>Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.</measure>
    <time_frame>From Week 2 to Week12</time_frame>
    <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.</measure>
    <time_frame>From Week 2 to Week12</time_frame>
    <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage Decrease of the Glucocorticoid Dose From Baseline.</measure>
    <time_frame>From Day 1 to Week12</time_frame>
    <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With at Least One Adverse Event.</measure>
    <time_frame>From Day 1 to Week 16</time_frame>
    <description>All adverse events collected from start of study treatment up to 28 days after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With at Least One Serious Adverse Event Including Death.</measure>
    <time_frame>From Informed consent to Week 16</time_frame>
    <description>Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Macrophage Activation Syndrome (MAS).</measure>
    <time_frame>From Day 1 to Week 16</time_frame>
    <description>Proportion of patients with Macrophage Activation Syndrome (MAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.</measure>
    <time_frame>Week 2</time_frame>
    <description>Proportion of patients with antidrug antibodies (ADA) against anakinra.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Neutralizing Antibodies.</measure>
    <time_frame>Week 2</time_frame>
    <description>Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pre-dose Concentrations.</measure>
    <time_frame>Week 2</time_frame>
    <description>Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pharmacokinetic Parameters: Cmax,</measure>
    <time_frame>Week 12</time_frame>
    <description>PK parameters only available for 2 patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pharmacokinetic Parameters, Tmax and T½</measure>
    <time_frame>Week 12</time_frame>
    <description>PK parameters only available for 2 patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h</measure>
    <time_frame>Week 12</time_frame>
    <description>PK parameters only available for 2 patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pharmacokinetic Parameter: CL/F</measure>
    <time_frame>Week 12</time_frame>
    <description>Pharmacokinetic parameters only available for 2 patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anakinra Serum Pharmacokinetic Parameter: Vd/F</measure>
    <time_frame>Week 12</time_frame>
    <description>PK parameters only available for 2 patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in JADAS27.</measure>
    <time_frame>Week 2</time_frame>
    <description>Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values &lt;10 mg/l are converted to 10 and CRP values &gt;110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57.&#xD;
Only results from Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Days Off School or Work Due to Still's Disease.</measure>
    <time_frame>Week 2</time_frame>
    <description>Number of days off school or work due to Still's disease week 1-2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Patients With Inactive Disease.</measure>
    <time_frame>Week 12</time_frame>
    <description>Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in IL-6.</measure>
    <time_frame>Week 2</time_frame>
    <description>Only results from Week 2 reported here.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in IL-18.</measure>
    <time_frame>Week 2</time_frame>
    <description>Only results from Week 2 reported here</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Serum Calprotectin.</measure>
    <time_frame>Week 2</time_frame>
    <description>Change from baseline in serum calprotectin. Only results from Week 2 reported here</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Neopterin.</measure>
    <time_frame>Week 2</time_frame>
    <description>Only results from Week 2 reported here</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">13</enrollment>
  <condition>Still's Disease, Adult-Onset</condition>
  <condition>Still's Disease, Juvenile-Onset</condition>
  <arm_group>
    <arm_group_label>anakinra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>anakinra</intervention_name>
    <description>sub cutaneous injection</description>
    <arm_group_label>anakinra</arm_group_label>
    <other_name>Kineret</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>sub cutaneous injection</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent.&#xD;
&#xD;
          2. Male and female patients with a body weight ≥ 10 kg.&#xD;
&#xD;
          3. Diagnosis of Still's disease.&#xD;
&#xD;
          4. If currently on glucocorticoid treatment, a stable dose for at least 1 week prior to&#xD;
             randomization.&#xD;
&#xD;
          5. If currently on methotrexate treatment, a stable dose for at least 8 weeks prior to&#xD;
             randomization.&#xD;
&#xD;
          6. Active disease.&#xD;
&#xD;
          7. Female patients of childbearing potential must use an effective method of&#xD;
             contraception during the study (abstinence being a possible option) as well as present&#xD;
             a negative pregnancy test prior to randomization.&#xD;
&#xD;
          8. Negative interferon-gamma release assay or Purified protein derivative ( PPD) test&#xD;
             within 2 months prior to randomization. If not available, a test should be performed&#xD;
             at day of randomization.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosis of Still's disease more than 6 months prior to randomization.&#xD;
&#xD;
          2. Previous randomization into this study.&#xD;
&#xD;
          3. Participation in another concurrent clinical interventional study within 30 days of&#xD;
             randomization.&#xD;
&#xD;
          4. Treatment with an investigational drug within 5 half-lives prior to randomization.&#xD;
&#xD;
          5. Previous or current treatment with anakinra, canakinumab or any other IL-1 inhibitor.&#xD;
&#xD;
          6. Use of the following therapies prior to randomization:&#xD;
&#xD;
               -  Narcotic analgesics within 24 hours prior to randomization.&#xD;
&#xD;
               -  Dapsone or etanercept within 3 weeks prior to randomization.&#xD;
&#xD;
               -  Intraarticular, intramuscular or intravenous administration of glucocorticoids or&#xD;
                  intravenous immunoglobulin (Ig) within 4 weeks prior to randomization.&#xD;
&#xD;
               -  Intravenous Ig with proven Still's disease modifying effect, leflunomide,&#xD;
                  infliximab or adalimumab within 8 weeks prior to randomization.&#xD;
&#xD;
               -  Thalidomide, cyclosporine, mycophenolate mofetil, 6-mercaptopurine, azathioprine,&#xD;
                  cyclophosphamide, chlorambucil or any other immunosuppressant within 12 weeks&#xD;
                  prior to randomization.&#xD;
&#xD;
               -  Tocilizumab within 12 weeks prior to randomization or any other immunomodulatory&#xD;
                  medication within 4 half-lives prior to randomization&#xD;
&#xD;
               -  Rituximab within 26 weeks prior to randomization.&#xD;
&#xD;
          7. Live vaccines within 1 month prior to randomization.&#xD;
&#xD;
          8. Known presence or suspicion of active, chronic or recurrent bacterial, fungal or viral&#xD;
             infections, including tuberculosis, HIV infection or hepatitis B or C infection.&#xD;
&#xD;
          9. Clinical evidence of liver disease or liver injury.&#xD;
&#xD;
         10. Presence of severe renal function impairment.&#xD;
&#xD;
         11. Presence of neutropenia.&#xD;
&#xD;
         12. Presence or suspicion of MAS at baseline.&#xD;
&#xD;
         13. A diagnosis of MAS within the last 2 months prior to randomization.&#xD;
&#xD;
         14. History of malignancy within 5 years.&#xD;
&#xD;
         15. Known hypersensitivity to E coli-derived proteins, or any components of Kineret®&#xD;
             (anakinra).&#xD;
&#xD;
         16. Pregnant or lactating women.&#xD;
&#xD;
         17. Foreseeable inability to cooperate with given instructions or study procedures.&#xD;
&#xD;
         18. Presence of any medical or psychological condition or laboratory result that in the&#xD;
             opinion of the investigator can interfere with the patient's ability to comply with&#xD;
             the protocol requirements or makes the patient not appropriate for inclusion to the&#xD;
             study and treatment with IMP.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sven Ohlman, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Swedish Orphan Biovitrum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Attune Health</name>
      <address>
        <city>Beverly Hills</city>
        <state>California</state>
        <zip>90211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rady Children's Hospital &amp; Health Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nicklaus Children's Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33155</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital and Clinics</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Louisville School of Medicine Research Foundation</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston Children's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Paul Rheumatology</name>
      <address>
        <city>Eagan</city>
        <state>Minnesota</state>
        <zip>55121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute for Rheumatic and Autoimmune Diseases</name>
      <address>
        <city>Summit</city>
        <state>New Jersey</state>
        <zip>07901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UNC Hospitals</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Children's Hospital and Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Brenner Medical Center</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Pittsburgh of UPMC</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monroe Carell Jr. Children's Hospital at Vanderbilt</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Research Institute</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Univ of TX Southwestern Medical Center Dallas - Texas Scottish Rite Hospital for Children</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah Hospitals and Clinics</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84113</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical College of Wisconsin</name>
      <address>
        <city>Milwaukee</city>
        <state>Wisconsin</state>
        <zip>53226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary - Alberta Children's Hospital</name>
      <address>
        <city>Calgary</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Calgary</name>
      <address>
        <city>Calgary</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <results_first_submitted>February 12, 2020</results_first_submitted>
  <results_first_submitted_qc>April 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 28, 2020</results_first_posted>
  <last_update_submitted>June 9, 2021</last_update_submitted>
  <last_update_submitted_qc>June 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interleukin 1 receptor antagonist</keyword>
  <keyword>IL-1 receptor antagonist</keyword>
  <keyword>Kineret</keyword>
  <keyword>anakinra</keyword>
  <keyword>Adult-Onset Still's Disease</keyword>
  <keyword>Systemic Juvenile Idiopathic Arthritis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis, Juvenile</mesh_term>
    <mesh_term>Still's Disease, Adult-Onset</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Interleukin 1 Receptor Antagonist Protein</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03265132/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 24, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/32/NCT03265132/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Anakinra</title>
          <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
        </group>
        <group group_id="P2">
          <title>Placebo</title>
          <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="6">One patient failed disease specific inclusion criteria and was excluded from efficacy analysis</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lack of Efficacy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Progressive disease</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Placebo</title>
          <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
        </group>
        <group group_id="B2">
          <title>Anakinra</title>
          <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="5"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="11"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14.4" spread="13.2"/>
                    <measurement group_id="B2" value="12.3" spread="19.3"/>
                    <measurement group_id="B3" value="13.3" spread="16.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Still's disease symptom duration</title>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32.4" spread="18.7"/>
                    <measurement group_id="B2" value="109.0" spread="78.0"/>
                    <measurement group_id="B3" value="74.2" spread="69.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.</title>
        <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline. (ACR: American College of Rheumatology)&#xD;
Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).&#xD;
Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).&#xD;
Number of joints with active arthritis.&#xD;
Number of joints with limitation of motion.&#xD;
Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).&#xD;
C-Reactive Protein (CRP) (mg/L).</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.</title>
          <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline. (ACR: American College of Rheumatology)&#xD;
Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).&#xD;
Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).&#xD;
Number of joints with active arthritis.&#xD;
Number of joints with limitation of motion.&#xD;
Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).&#xD;
C-Reactive Protein (CRP) (mg/L).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0022</p_value>
            <method>Fisher Exact</method>
            <param_type>Risk Difference (RD)</param_type>
            <param_value>1.0</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.42</ci_lower_limit>
            <ci_upper_limit>1.00</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
        <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
          <description>ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
        <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
          <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
        <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
          <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
        <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.</title>
          <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
        <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
          <description>ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
        <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
          <description>ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
        <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.</title>
          <description>ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by &gt;30% from baseline.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in Physician Global Assessment of Disease Activity.</title>
        <description>Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in Physician Global Assessment of Disease Activity.</title>
          <description>Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.</title>
        <description>Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.</title>
          <description>Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in Number of Joints With Active Arthritis.</title>
        <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in Number of Joints With Active Arthritis.</title>
          <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in Number of Joints With Limitation of Motion.</title>
        <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in Number of Joints With Limitation of Motion.</title>
          <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).</title>
        <description>Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).</title>
          <description>Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Responders in CRP (mg/L).</title>
        <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Responders in CRP (mg/L).</title>
          <description>Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.</title>
        <description>Proportion of patients with absence of fever during the 7 days preceding Week 2.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.</title>
          <description>Proportion of patients with absence of fever during the 7 days preceding Week 2.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.</title>
        <description>Absence of fever during the 24 hours preceding week 1.</description>
        <time_frame>Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.</title>
          <description>Absence of fever during the 24 hours preceding week 1.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.</title>
        <description>Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
        <time_frame>Day 1 and Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.</title>
          <description>Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-46.3" spread="32.6"/>
                    <measurement group_id="O2" value="-30.0" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.</title>
        <description>Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
        <time_frame>Day 1 and Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.</title>
          <description>Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-53.7" spread="27.7"/>
                    <measurement group_id="O2" value="-25.0" spread="31.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CRP.</title>
        <description>Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.</description>
        <time_frame>Day 1 and Week 1</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CRP.</title>
          <description>Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-109.6" spread="63.4"/>
                    <measurement group_id="O2" value="-22.7" spread="47.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.</title>
        <description>Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.</title>
          <description>Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.</title>
        <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.</description>
        <time_frame>Week 2, Week 4, Week 8 and Week 12</time_frame>
        <population>No patients were treated with any systemic glucocorticoids at randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.</title>
          <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.</description>
          <population>No patients were treated with any systemic glucocorticoids at randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Absence of Rash.</title>
        <description>Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Absence of Rash.</title>
          <description>Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in CRP.</title>
        <description>Change from baseline in CRP. Results at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in CRP.</title>
          <description>Change from baseline in CRP. Results at Week 2 reported here.</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-126.670" spread="66.697"/>
                    <measurement group_id="O2" value="-33.904" spread="64.393"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.</title>
        <description>Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.</title>
          <description>Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.</description>
          <units>g/dL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.57" spread="0.86"/>
                    <measurement group_id="O2" value="-0.80" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Platelet Count.</title>
        <description>Change from baseline in platelet count. Results at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Platelet Count.</title>
          <description>Change from baseline in platelet count. Results at Week 2 reported here.</description>
          <units>10^9/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-148.2" spread="52.3"/>
                    <measurement group_id="O2" value="-26.3" spread="139.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Ferritin.</title>
        <description>Change from baseline in ferritin. Results at Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Ferritin.</title>
          <description>Change from baseline in ferritin. Results at Week 2 reported here.</description>
          <units>ug/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-390.364" spread="387.521"/>
                    <measurement group_id="O2" value="-49.383" spread="51.776"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.</title>
        <description>Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).</description>
        <time_frame>Week 2</time_frame>
        <population>Patients with baseline and week 2 data analyzed.</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.</title>
          <description>Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).</description>
          <population>Patients with baseline and week 2 data analyzed.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-55.6" spread="27.7"/>
                    <measurement group_id="O2" value="-33.5" spread="28.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Study Drug Discontinuation for Any Reason.</title>
        <description>Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.</description>
        <time_frame>From Day 1 to Week12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Study Drug Discontinuation for Any Reason.</title>
          <description>Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.</title>
        <description>Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.</description>
        <time_frame>From Day 1 to Week12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.</title>
          <description>Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.</title>
        <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
        <time_frame>From Week 2 to Week12</time_frame>
        <population>No patients were treated with any systemic glucocorticoids at randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.</title>
          <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
          <population>No patients were treated with any systemic glucocorticoids at randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.</title>
        <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
        <time_frame>From Week 2 to Week12</time_frame>
        <population>No patients were treated with any systemic glucocorticoids at randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.</title>
          <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
          <population>No patients were treated with any systemic glucocorticoids at randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage Decrease of the Glucocorticoid Dose From Baseline.</title>
        <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
        <time_frame>From Day 1 to Week12</time_frame>
        <population>No patients were treated with any systemic glucocorticoids at randomization</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage Decrease of the Glucocorticoid Dose From Baseline.</title>
          <description>Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available</description>
          <population>No patients were treated with any systemic glucocorticoids at randomization</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With at Least One Adverse Event.</title>
        <description>All adverse events collected from start of study treatment up to 28 days after stopping study treatment.</description>
        <time_frame>From Day 1 to Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With at Least One Adverse Event.</title>
          <description>All adverse events collected from start of study treatment up to 28 days after stopping study treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With at Least One Serious Adverse Event Including Death.</title>
        <description>Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.</description>
        <time_frame>From Informed consent to Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With at Least One Serious Adverse Event Including Death.</title>
          <description>Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Macrophage Activation Syndrome (MAS).</title>
        <description>Proportion of patients with Macrophage Activation Syndrome (MAS).</description>
        <time_frame>From Day 1 to Week 16</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Macrophage Activation Syndrome (MAS).</title>
          <description>Proportion of patients with Macrophage Activation Syndrome (MAS).</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.</title>
        <description>Proportion of patients with antidrug antibodies (ADA) against anakinra.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.</title>
          <description>Proportion of patients with antidrug antibodies (ADA) against anakinra.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Neutralizing Antibodies.</title>
        <description>Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Neutralizing Antibodies.</title>
          <description>Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="6"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pre-dose Concentrations.</title>
        <description>Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <population>No data available for the placebo group as they did not receive anakinra.</population>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pre-dose Concentrations.</title>
          <description>Week 2 reported here.</description>
          <population>No data available for the placebo group as they did not receive anakinra.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="157" spread="134"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pharmacokinetic Parameters: Cmax,</title>
        <description>PK parameters only available for 2 patients.</description>
        <time_frame>Week 12</time_frame>
        <population>PK parameters only available for 2 anakinra treated patients.</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pharmacokinetic Parameters: Cmax,</title>
          <description>PK parameters only available for 2 patients.</description>
          <population>PK parameters only available for 2 anakinra treated patients.</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1990.0" spread="1315.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pharmacokinetic Parameters, Tmax and T½</title>
        <description>PK parameters only available for 2 patients</description>
        <time_frame>Week 12</time_frame>
        <population>PK parameters only available for 2 patients</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pharmacokinetic Parameters, Tmax and T½</title>
          <description>PK parameters only available for 2 patients</description>
          <population>PK parameters only available for 2 patients</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Tmax</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="3.06" spread="1.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>T½</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="5.23" spread="1.01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h</title>
        <description>PK parameters only available for 2 patients</description>
        <time_frame>Week 12</time_frame>
        <population>PK parameters only available for 2 anakinra treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h</title>
          <description>PK parameters only available for 2 patients</description>
          <population>PK parameters only available for 2 anakinra treated patients</population>
          <units>h*ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="18483.3" spread="15708.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pharmacokinetic Parameter: CL/F</title>
        <description>Pharmacokinetic parameters only available for 2 patients</description>
        <time_frame>Week 12</time_frame>
        <population>Pharmacokinetic parameters only available for 2 anakinra treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pharmacokinetic Parameter: CL/F</title>
          <description>Pharmacokinetic parameters only available for 2 patients</description>
          <population>Pharmacokinetic parameters only available for 2 anakinra treated patients</population>
          <units>mL/h*kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="170.80" spread="45.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Anakinra Serum Pharmacokinetic Parameter: Vd/F</title>
        <description>PK parameters only available for 2 patients</description>
        <time_frame>Week 12</time_frame>
        <population>PK parameters only available for 2 anakinra treated patients</population>
        <group_list>
          <group group_id="O1">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Anakinra Serum Pharmacokinetic Parameter: Vd/F</title>
          <description>PK parameters only available for 2 patients</description>
          <population>PK parameters only available for 2 anakinra treated patients</population>
          <units>mL/kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O2" value="1254.52" spread="95.57"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in JADAS27.</title>
        <description>Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values &lt;10 mg/l are converted to 10 and CRP values &gt;110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57.&#xD;
Only results from Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in JADAS27.</title>
          <description>Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values &lt;10 mg/l are converted to 10 and CRP values &gt;110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57.&#xD;
Only results from Week 2 reported here.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-21.42" spread="3.93"/>
                    <measurement group_id="O2" value="-15.81" spread="4.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Days Off School or Work Due to Still's Disease.</title>
        <description>Number of days off school or work due to Still's disease week 1-2.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Days Off School or Work Due to Still's Disease.</title>
          <description>Number of days off school or work due to Still's disease week 1-2.</description>
          <units>Days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="1.6"/>
                    <measurement group_id="O2" value="1.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Proportion of Patients With Inactive Disease.</title>
        <description>Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.</description>
        <time_frame>Week 12</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Proportion of Patients With Inactive Disease.</title>
          <description>Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in IL-6.</title>
        <description>Only results from Week 2 reported here.</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IL-6.</title>
          <description>Only results from Week 2 reported here.</description>
          <units>ng/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-30.048" spread="23.262"/>
                    <measurement group_id="O2" value="-24.818" spread="25.940"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in IL-18.</title>
        <description>Only results from Week 2 reported here</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in IL-18.</title>
          <description>Only results from Week 2 reported here</description>
          <units>ng/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7968.0" spread="7564.4"/>
                    <measurement group_id="O2" value="-20701.7" spread="32766.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Serum Calprotectin.</title>
        <description>Change from baseline in serum calprotectin. Only results from Week 2 reported here</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Serum Calprotectin.</title>
          <description>Change from baseline in serum calprotectin. Only results from Week 2 reported here</description>
          <units>mg/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="6"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-100.038" spread="113.349"/>
                    <measurement group_id="O2" value="-26.021" spread="23.819"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Neopterin.</title>
        <description>Only results from Week 2 reported here</description>
        <time_frame>Week 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Anakinra</title>
            <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
          </group>
          <group group_id="O2">
            <title>Placebo</title>
            <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Neopterin.</title>
          <description>Only results from Week 2 reported here</description>
          <units>nmol/L</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.08" spread="5.69"/>
                    <measurement group_id="O2" value="-8.00" spread="10.82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the start of study treatment up to 28 days after stopping study treatment.</time_frame>
      <desc>The Investigator recorded all directly observed AEs, and all AEs spontaneously reported by the patient, in the CRF. MAS was defined as an event of special interest in this study. If a MAS diagnosis was made at any point after patient signed informed consent, the event was to be reported as a serious AE and the patient should be withdrawn from the study.</desc>
      <group_list>
        <group group_id="E1">
          <title>Anakinra</title>
          <description>2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)&#xD;
anakinra: sub cutaneous injection</description>
        </group>
        <group group_id="E2">
          <title>Placebo</title>
          <description>Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day&#xD;
Placebo: sub cutaneous injection</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Diffuse large B-cell lymphoma stage III</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="6"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Retching</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection site reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site erythema</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Injection site rash</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Upper respiratory infection</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Ear infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Viral upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Joint injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Thermal burn</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Vitamin D decrease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Neuralgia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Rhinorrhoea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Nasal congestion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Night sweats</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
              <event>
                <sub_title>Urticaria</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="6"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="6"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Kineret Clinical Program Leader</name_or_title>
      <organization>Swedish Orphan Biovitrum</organization>
      <phone>+46(8)6972000</phone>
      <email>info@sobi.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03265132
org study id: Sobi.ANAKIN-301
nct id: NCT03265132
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The aim of this study is to demonstrate the efficacy and to evaluate the safety,
      pharmacokinetics (PK) and immunogenicity of anakinra in patients with newly diagnosed Still's
      disease, including SJIA (Systemic juvenile idiopathic arthritis) and AOSD (Adult-onset
      Still's disease).
The study consists of a 12-week, randomized, double-blind, placebo controlled period with two
      dose levels of anakinra and a 4-week safety follow-up after last dose of investigational
      medicinal product (IMP). The primary endpoint will be evaluated at Week 2. Sustained efficacy
      and time to study drug discontinuation will be evaluated during the full study period.

      A screening visit is optional and may be done to identify patients that could be suitable for
      the study. During the study 6 visits and 2 telephone contacts are scheduled i.e., Day 1
      (baseline visit), Day 4Tel, Week 1, Week 2, Week 4, Week 8, Week 12 and Week 16Tel (End of
      Study).

      Patients will be randomly assigned to study drug, after they meet all of the inclusion
      criteria and none of the exclusion criteria. Patients will receive treatment for 12 weeks,
      either anakinra or placebo. Patients will be randomized to anakinra in a dose of either 2 or
      4 mg/kg/day, with a maximum dose of 100 or 200 mg once daily, respectively. Patients will be
      randomized to placebo with corresponding volumes for each of the two anakinra dose levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Proportion of ACR30 Responders With Absence of Fever Attributable to the Disease During the 7 Days Preceding Week 2.
time frame: Week 2
description: ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed below. Also no more than 1 of the 6 variables may worsen by >30% from baseline. (ACR: American College of Rheumatology)
Physician global assessment of disease activity - Assessed on a Visual Analogue Scale (VAS) from no disease activity (0 mm) to very severe disease activity (100 mm).
Patient/parent global assessment of overall well-being - Assessed on a VAS from very well (0 mm) to very poor (100 mm).
Number of joints with active arthritis.
Number of joints with limitation of motion.
Assessment of physical function - Patient Reported Outcome instruments : Childhood Health Assessment Questionnaire (CHAQ) /Stanford Health Assessment Questionnaire (SHAQ).
C-Reactive Protein (CRP) (mg/L).
measure: Proportion of ACR30 Responders With Absence of Fever During 24 Hours Preceding Week 1.
time frame: Week 1
description: ACR30 response is defined as an improvement of ≥ 30% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR50 Responders With Absence of Fever During 24 Hours Preceding Week 1.
time frame: Week 1
description: ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR70 Responders With Absence of Fever During 24 Hours Preceding Week 1.
time frame: Week 1
description: ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR90 Responders With Absence of Fever During 24 Hours Preceding Week 1.
time frame: Week 1
description: ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR50 Responders With Absence of Fever During 7 Days Preceding Week 2.
time frame: Week 2
description: ACR50 response is defined as an improvement of ≥ 50% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome measure. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR70 Responders With Absence of Fever During 7 Days Preceding Week 2.
time frame: Week 2
description: ACR70 response is defined as an improvement of ≥ 70% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome. Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of ACR90 Responders With Absence of Fever During 7 Days Preceding Week 2.
time frame: Week 2
description: ACR90 response is defined as an improvement of ≥ 90% from baseline in at least 3 of any 6 variables listed in the description of the primary outcome . Also no more than 1 of the 6 variables may worsen by >30% from baseline.
measure: Proportion of Responders in Physician Global Assessment of Disease Activity.
time frame: Week 2
description: Assessed on a VAS from no disease activity (0 mm) to very severe disease activity (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Responders in Patient/Parent Global Assessment of Overall Well-being.
time frame: Week 2
description: Assessed on a VAS from very well (0 mm) to very poor. (100 mm). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Responders in Number of Joints With Active Arthritis.
time frame: Week 2
description: Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Responders in Number of Joints With Limitation of Motion.
time frame: Week 2
description: Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline.Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Responders in Assessment of Physical Function (CHAQ/SHAQ).
time frame: Week 2
description: Childhood Health Assessment Questionnaire (CHAQ) and Stanford Health Assessment Questionnaire (SHAQ) assess physical and functional status (see Clinical protocol section 6.5.4.1.5). Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Responders in CRP (mg/L).
time frame: Week 2
description: Response is defined as an improvement of ≥ 30%, 50%, 70% and 90% from baseline. Only improvement of ≥90% at Week 2 reported here.
measure: Proportion of Patients With Absence of Fever During the 7 Days Preceding Week 2.
time frame: Week 2
description: Proportion of patients with absence of fever during the 7 days preceding Week 2.
measure: Proportion of Patients With Absence of Fever During the 24 Hours Preceding Week 1.
time frame: Week 1
description: Absence of fever during the 24 hours preceding week 1.
measure: Change From Baseline in Physician Global Assessment of Disease Activity at Week 1.
time frame: Day 1 and Week 1
description: Change from baseline in Physician global assessment of disease activity measured on a VAS 0 (very well)-100 (very poor) at Week 1.
measure: Change From Baseline in Patient/Parent Global Assessment of Overall Well-being at Week 1.
time frame: Day 1 and Week 1
description: Change from baseline in patient/parent global assessment of overall well-being measured on a VAS 0 (very well)-100 (very poor) at Week 1.
measure: Change From Baseline in CRP.
time frame: Day 1 and Week 1
description: Change from baseline in C-Reactive Protein (CRP). CRP is measured in mg/L.
measure: Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response.
time frame: Week 12
description: Proportion of patients that still meet the corresponding week 2 response with absence of fever in the preceding 7 days. Only the strictest criteria, ACR90, is reported here.
measure: Proportion of Patients With Sustained ACR30, ACR50, ACR70 and ACR90 Response in Relation to Glucocorticoid Tapering.
time frame: Week 2, Week 4, Week 8 and Week 12
description: Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available.
measure: Proportion of Patients With Absence of Rash.
time frame: Week 2
description: Absence of rash is evaluated 24 hours preceding Week 1 and 7 days preceding Week 2, Week 4, Week 8 and Week 12. Only data at Week 2 reported here.
measure: Change From Baseline in CRP.
time frame: Week 2
description: Change from baseline in CRP. Results at Week 2 reported here.
measure: Change From Baseline in Hemoglobin (Hb). Results at Week 2 Reported Here.
time frame: Week 2
description: Change from baseline in Hemoglobin (Hb). Results at Week 2 reported here.
measure: Change From Baseline in Platelet Count.
time frame: Week 2
description: Change from baseline in platelet count. Results at Week 2 reported here.
measure: Change From Baseline in Ferritin.
time frame: Week 2
description: Change from baseline in ferritin. Results at Week 2 reported here.
measure: Change From Baseline in Patient/Parent Global Assessment of Disease Related Pain.
time frame: Week 2
description: Assessed on a VAS from no pain (0 mm) to very severe pain (100 mm).
measure: Time to Study Drug Discontinuation for Any Reason.
time frame: From Day 1 to Week12
description: Time to study drug discontinuation was analyzed using Kaplan-Meier curves. Number of patients with premature study drug discontinuation for any reason is reported here.
measure: Time to Study Drug Discontinuation Due to Lack of Efficacy or Progressive Disease.
time frame: From Day 1 to Week12
description: Proportion of study drug discontinuation due to lack of efficacy or progressive disease was analyzed using Kaplan-Meier curves. Number of patients discontinuing study drug due to lack of efficacy or progressive disease is reported here.
measure: Proportion of Patients Who Have Initiated Tapering of Glucocorticoids.
time frame: From Week 2 to Week12
description: Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
measure: Proportion of Patients That Have Decreased the Glucocorticoid Dose With at Least 50% From Baseline.
time frame: From Week 2 to Week12
description: Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
measure: Percentage Decrease of the Glucocorticoid Dose From Baseline.
time frame: From Day 1 to Week12
description: Please note no patients were treated with any systemic glucocorticoids at randomization. Hence no results available
measure: Proportion of Patients With at Least One Adverse Event.
time frame: From Day 1 to Week 16
description: All adverse events collected from start of study treatment up to 28 days after stopping study treatment.
measure: Proportion of Patients With at Least One Serious Adverse Event Including Death.
time frame: From Informed consent to Week 16
description: Serious adverse events (SAEs) will be collected from informed consent up to 28 days after stopping study treatment.
measure: Proportion of Patients With Macrophage Activation Syndrome (MAS).
time frame: From Day 1 to Week 16
description: Proportion of patients with Macrophage Activation Syndrome (MAS).
measure: Proportion of Patients With Antidrug Antibodies (ADA) Against Anakinra.
time frame: Week 2
description: Proportion of patients with antidrug antibodies (ADA) against anakinra.
measure: Proportion of Patients With Neutralizing Antibodies.
time frame: Week 2
description: Confirmed ADA positive samples will be analyzed for the presence of neutralizing antibodies.
measure: Anakinra Serum Pre-dose Concentrations.
time frame: Week 2
description: Week 2 reported here.
measure: Anakinra Serum Pharmacokinetic Parameters: Cmax,
time frame: Week 12
description: PK parameters only available for 2 patients.
measure: Anakinra Serum Pharmacokinetic Parameters, Tmax and T½
time frame: Week 12
description: PK parameters only available for 2 patients
measure: Anakinra Serum Pharmacokinetic Parameter: AUC 0-24 h
time frame: Week 12
description: PK parameters only available for 2 patients
measure: Anakinra Serum Pharmacokinetic Parameter: CL/F
time frame: Week 12
description: Pharmacokinetic parameters only available for 2 patients
measure: Anakinra Serum Pharmacokinetic Parameter: Vd/F
time frame: Week 12
description: PK parameters only available for 2 patients
measure: Change From Baseline in JADAS27.
time frame: Week 2
description: Juvenile Arthritis Disease Activity Score (JADAS) includes 4 measures: physician global assessment of disease activity, patient or parent global assessment of overall well-being, 27 active joint count, and CRP. The JADAS27 includes the 27 joints. JADAS27 is calculated as the sum of its four components, physician global assessment of disease activity converted to cm from the VAS (0=no activity, 10=maximum activity); patient global assessment of well-being converted to cm from the VAS (0=very well, 10=very poor); active joint count (0-27); and CRP. Prior to calculation CRP is truncated to a 0 - 10 scale according to the following formula: (CRP (mg/l) -10)/10. Before calculation, CRP values <10 mg/l are converted to 10 and CRP values >110 mg/l are converted to 110. The JADAS27 tool yields a global score of 0-57.
Only results from Week 2 reported here.
measure: Number of Days Off School or Work Due to Still's Disease.
time frame: Week 2
description: Number of days off school or work due to Still's disease week 1-2.
measure: Proportion of Patients With Inactive Disease.
time frame: Week 12
description: Inactive disease is a composite of the following parameters: no joints with active arthritis, no fever, no rash, no serositis, no splenomegaly, no generalized lymphadenopathy attributable to Still's disease, CRP level within normal limits, physician's global assessment of disease activity score below 10 mm on a 100 mm VAS and a documented morning stiffness ≤15 minutes.
measure: Change From Baseline in IL-6.
time frame: Week 2
description: Only results from Week 2 reported here.
measure: Change From Baseline in IL-18.
time frame: Week 2
description: Only results from Week 2 reported here
measure: Change From Baseline in Serum Calprotectin.
time frame: Week 2
description: Change from baseline in serum calprotectin. Only results from Week 2 reported here
measure: Change From Baseline in Neopterin.
time frame: Week 2
description: Only results from Week 2 reported here
arm group label: anakinra
arm group type: Experimental
description: 2 mg/kg/day (max 100 mg/day) or 4 mg/kg/day (max 200 mg/day)
arm group label: Placebo
arm group type: Placebo Comparator
description: Corresponding volume to anakinra 2 mg/kg/day or 4 mg/kg/day
intervention type: Biological
intervention name: anakinra
description: sub cutaneous injection
arm group label: anakinra
other name: Kineret
intervention type: Drug
intervention name: Placebo
description: sub cutaneous injection
arm group label: Placebo
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sven Ohlman, MD PhD
role: Study Director
affiliation: Swedish Orphan Biovitrum
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country: Canada
country: United States
responsible party type: Sponsor
mesh term: Arthritis, Juvenile
mesh term: Still's Disease, Adult-Onset
mesh term: Interleukin 1 Receptor Antagonist Protein
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 