xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06011889</url>
    </required_header>
    <id_info>
      <org_study_id>NIGRIR_003SAPHO</org_study_id>
      <nct_id>NCT06011889</nct_id>
    </id_info>
    <brief_title>Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome</brief_title>
    <acronym>SAPHO</acronym>
    <official_title>A Multicenter, Randomized, Double-blind Clinical Trial Evaluating the Efficacy and Safety of Etanercept Versus Placebo in the Treatment of Patients With SAPHO Syndrome</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Medical Research Agency, Poland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified&#xD;
        classification criteria according to Kahn (2003), with the ineffectiveness of standard&#xD;
        treatment (patient's global assessment of the disease on the VAS scale greater than or equal&#xD;
        to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with&#xD;
        non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical&#xD;
        disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 13, 2023</start_date>
    <completion_date type="Anticipated">October 18, 2028</completion_date>
    <primary_completion_date type="Anticipated">October 18, 2028</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent</measure>
      <time_frame>12 weeks (day 85)</time_frame>
      <description>Change in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in patient-assessed disease activity</measure>
      <time_frame>after 4 and 8 weeks</time_frame>
      <description>Change in patient-assessed disease activity - a minimum 50 percent decrease in patient-assessed Visual Analogue Scale overall disease activity from the randomization score at weeks 4 and 8 and a minimum 50 percent decrease in patient-assessed Visual Analogue Scale pain from the score on daily basis randomization after 4 and 8 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of remission</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>Occurrence of remission - complete resolution of osteoarticular and skin complaints in the patient's assessment - after 4, 8 and 12 weeks from randomization day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of partial remission</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>Occurrence of partial remission - complete resolution of osteoarticular or skin symptoms in the patient's assessment - after 4, 8 and 12 weeks from randomization day</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of the patient acceptable symptom state (PASS score)</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>Occurrence of the patient acceptable symptom state (PASS score) after 4, 8 and 12 weeks from randomization day. Possible answer- &quot;yes&quot; or &quot;no&quot;, with &quot;yes&quot; means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physician-assessed disease activity</measure>
      <time_frame>at 4, 8 and 12 week</time_frame>
      <description>Improvement in physician-assessed disease activity - a minimum 50 percent decrease in physician-assessed overall disease activity on the Visual Analogue Scale from the randomization score at 4, 8 and 12 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the C-reactive Protein from Randomization Day Score</measure>
      <time_frame>at Weeks 4, 8 and 12</time_frame>
      <description>Change in C-reactive Protein from Randomization Day Score at Weeks 4, 8 and 12. A decrease in C-reactive Protein means improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Erythrocyte Sedimentation Rate from Randomization Day Score</measure>
      <time_frame>at Weeks 4, 8 and 12</time_frame>
      <description>Change in the Erythrocyte Sedimentation Rate Score from Randomization Day Score at Weeks 4, 8 and 12. A decrease in the Erythrocyte Sedimentation Rate Score means improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in quality of life on the Short Form-36 health survey</measure>
      <time_frame>at 4, 8 and 12 weeks</time_frame>
      <description>Change in quality of life on the Short Form -36 (SF-36) health survey from the score on the day of randomization at 4, 8 and 12 weeks. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score after 4, 8 and 12 weeks. WPAI contains four domains. For each domain, the minimum value is 0 percent, and the maximum is 100 percent. Decreased Work Productivity and Activity Impairments (WPAI) Score means improvement.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>In patients with axial involvement, a decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1 from the Randomization Day Score at weeks 4, 8, and 12. The minimum value is 0, the maximum value is infinity. A decrease means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent from the Randomization Day Score at weeks 4, 8, and 12 was achieved (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>status of remission - Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3 - after 4, 8 and 12 weeks from randomization day (applies to patients with axial involvement). A score below 1.3 means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>a decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent compared to the result on the day of randomization after 4, 8 and 12 weeks (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>In patients with severe acne - a decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>For patients with psoriasis: decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0 percent, and the maximum value is 100 percent. The decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent</measure>
      <time_frame>after 4, 8 and 12 weeks</time_frame>
      <description>For patients with psoriasis: decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>SAPHO Syndrome</condition>
    <arm_group>
      <arm_group_label>Etanercept</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Etanercept</intervention_name>
      <description>treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs</description>
      <arm_group_label>Etanercept</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of SAPHO syndrome according to modified Kahn criteria from 2003.&#xD;
  &#xD;
            2. Age over 18.&#xD;
  &#xD;
            3. Patient overall disease and pain assessment on VAS both ≥ 4 cm.&#xD;
  &#xD;
            4. Expressing informed consent to participate in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. According to the Summary of Product Characteristics (SmPC) for Enbrel.&#xD;
  &#xD;
            2. Pregnancy, breastfeeding, inability to use effective contraception during the&#xD;
               examination.&#xD;
  &#xD;
            3. Change in the dose of NSAIDs treatment in the last 4 weeks.&#xD;
  &#xD;
            4. Dose modification of disease-modifying antirheumatic drugs (DMARDs) over the past 12&#xD;
               weeks.&#xD;
  &#xD;
            5. Use of biological drugs / synthetic targeted drugs in the last 12 weeks.&#xD;
  &#xD;
            6. Use of corticosteroids (orally or local injections), bisphosphonates and/or&#xD;
               antibiotics in the last 4 weeks.&#xD;
  &#xD;
            7. Any medical condition that the investigator judges to contraindicate etanercept&#xD;
               treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jakub Wroński, PhD, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>National Institute of Geriatrics, Rheumatology and Rehabilitation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Jakub Wroński, PhD, MD</last_name>
      <phone>22 6880632</phone>
      <phone_ext>+48</phone_ext>
      <email>jakub.wronski@spartanska.pl</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centrum Wsparcia Badań Klinicznych</name>
        <address>
          <city>Warsaw</city>
          <state>Mazowieckie</state>
          <zip>02-637</zip>
          <country>Poland</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marta Kurek</last_name>
        <phone>603 315 033</phone>
        <phone_ext>+48</phone_ext>
        <email>marta.kurek@spartanska.pl</email>
      </contact>
      <contact_backup>
        <last_name>Agnieszka Kurowska</last_name>
        <phone>691 326 114</phone>
        <phone_ext>+48</phone_ext>
        <email>agnieszka.kurowska@spartanska.pl</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Poland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acquired Hyperostosis Syndrome</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Etanercept</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06011889
  org study id: NIGRIR_003SAPHO
  nct id: NCT06011889
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study includes adult patients with SAPHO syndrome (ORPHA: 793), meeting the modified
        classification criteria according to Kahn (2003), with the ineffectiveness of standard
        treatment (patient's global assessment of the disease on the VAS scale greater than or equal
        to 4 cm with accompanying pain on the VAS scale greater than or equal to 4 cm) treated with
        non-steroidal anti-inflammatory drugs in a stable dose for at least 4 weeks and/or classical
        disease-modifying antirheumatic drugs in stable doses for at least 12 weeks.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: Change in the scope of disease activity as assessed by the patient- a decrease in the overall disease activity on the Visual Analogue Scale by min. 50 percent and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent
  time frame: 12 weeks (day 85)
  description: Change in the scope of disease activity as assessed by the patient - a decrease in the overall disease activity as assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day and a decrease in pain assessed by the patient on the Visual Analogue Scale by min. 50 percent after 12 weeks from randomization day. The minimum value is - 0, and the maximum value is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
  measure: Change in patient-assessed disease activity
  time frame: after 4 and 8 weeks
  description: Change in patient-assessed disease activity - a minimum 50 percent decrease in patient-assessed Visual Analogue Scale overall disease activity from the randomization score at weeks 4 and 8 and a minimum 50 percent decrease in patient-assessed Visual Analogue Scale pain from the score on daily basis randomization after 4 and 8 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
  measure: Occurrence of remission
  time frame: after 4, 8 and 12 weeks
  description: Occurrence of remission - complete resolution of osteoarticular and skin complaints in the patient's assessment - after 4, 8 and 12 weeks from randomization day
  measure: Occurrence of partial remission
  time frame: after 4, 8 and 12 weeks
  description: Occurrence of partial remission - complete resolution of osteoarticular or skin symptoms in the patient's assessment - after 4, 8 and 12 weeks from randomization day
  measure: Occurrence of the patient acceptable symptom state (PASS score)
  time frame: after 4, 8 and 12 weeks
  description: Occurrence of the patient acceptable symptom state (PASS score) after 4, 8 and 12 weeks from randomization day. Possible answer- "yes" or "no", with "yes" means a better outcome.
  measure: Change in physician-assessed disease activity
  time frame: at 4, 8 and 12 week
  description: Improvement in physician-assessed disease activity - a minimum 50 percent decrease in physician-assessed overall disease activity on the Visual Analogue Scale from the randomization score at 4, 8 and 12 weeks. The minimum value is - 0, and the maximum is - 100 mm. The higher scores mean a worse outcome. A decrease by a minimum of 50 percent means a better outcome.
  measure: Change in the C-reactive Protein from Randomization Day Score
  time frame: at Weeks 4, 8 and 12
  description: Change in C-reactive Protein from Randomization Day Score at Weeks 4, 8 and 12. A decrease in C-reactive Protein means improvement.
  measure: Change in the Erythrocyte Sedimentation Rate from Randomization Day Score
  time frame: at Weeks 4, 8 and 12
  description: Change in the Erythrocyte Sedimentation Rate Score from Randomization Day Score at Weeks 4, 8 and 12. A decrease in the Erythrocyte Sedimentation Rate Score means improvement.
  measure: Change in quality of life on the Short Form-36 health survey
  time frame: at 4, 8 and 12 weeks
  description: Change in quality of life on the Short Form -36 (SF-36) health survey from the score on the day of randomization at 4, 8 and 12 weeks. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.
  measure: Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score
  time frame: after 4, 8 and 12 weeks
  description: Change in the Work Productivity and Activity Impairments (WPAI) from the Randomization Day Score after 4, 8 and 12 weeks. WPAI contains four domains. For each domain, the minimum value is 0 percent, and the maximum is 100 percent. Decreased Work Productivity and Activity Impairments (WPAI) Score means improvement.
  measure: decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1
  time frame: after 4, 8 and 12 weeks
  description: In patients with axial involvement, a decrease in Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) ≥1.1 from the Randomization Day Score at weeks 4, 8, and 12. The minimum value is 0, the maximum value is infinity. A decrease means a better outcome.
  measure: a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent
  time frame: after 4, 8 and 12 weeks
  description: a decrease in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score of at least 50 percent from the Randomization Day Score at weeks 4, 8, and 12 was achieved (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.
  measure: status of remission- Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3
  time frame: after 4, 8 and 12 weeks
  description: status of remission - Ankylosing Spondylitis Disease Activity Score (ASDAS- C-reactive protein) below 1.3 - after 4, 8 and 12 weeks from randomization day (applies to patients with axial involvement). A score below 1.3 means a better outcome.
  measure: decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent
  time frame: after 4, 8 and 12 weeks
  description: a decrease in the Bath Ankylosing Spondylitis Functional Index (BASFI) by a minimum of 50 percent compared to the result on the day of randomization after 4, 8 and 12 weeks (applies to patients with axial involvement). The minimum value is 0, the maximum value is 10. A decrease by a minimum of 50 percent means a better outcome.
  measure: decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization
  time frame: after 4, 8 and 12 weeks
  description: In patients with severe acne - a decrease in the Dermatology Life Quality Index (DLQI) by at least 50 percent from the result on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.
  measure: decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks
  time frame: after 4, 8 and 12 weeks
  description: For patients with psoriasis: decrease in Body Surface Area (BSA) index by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0 percent, and the maximum value is 100 percent. The decrease by a minimum of 50 percent means a better outcome.
  measure: decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent
  time frame: after 4, 8 and 12 weeks
  description: For patients with psoriasis: decrease in the Dermatology Life Quality Index (DLQI) by a minimum of 50 percent from the score on the day of randomization after 4, 8 and 12 weeks. The minimum value is 0, the maximum value is 30. The decrease by a minimum of 50 percent means a better outcome.
  arm group label: Etanercept
  arm group type: Experimental
  description: treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: treatment with placeboin addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
  intervention type: Drug
  intervention name: Etanercept
  description: treatment with etanercept in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
  arm group label: Etanercept
  intervention type: Drug
  intervention name: Placebo
  description: treatment with placebo in addition to NSAID treatment and/or classic Disease Modifying Antirheumatic Drugs
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jakub Wroński, PhD, MD
  role: Principal Investigator
  affiliation: National Institute of Geriatrics, Rheumatology and Rehabilitation
  last name: Jakub Wroński, PhD, MD
  phone: 22 6880632
  phone ext: +48
  email: jakub.wronski@spartanska.pl
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Poland
  responsible party type: Sponsor
  mesh term: Acquired Hyperostosis Syndrome
  mesh term: Syndrome
  mesh term: Etanercept