<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/NCT03000439</url>
  </required_header>
  <id_info>
    <org_study_id>A3921165</org_study_id>
    <secondary_id>2017-002018-29</secondary_id>
    <nct_id>NCT03000439</nct_id>
  </id_info>
  <brief_title>A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA</brief_title>
  <official_title>EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pfizer</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>
      A randomized withdrawal study in which responders to open-label treatment with tofacitinib&#xD;
      will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the&#xD;
      double-blind phase &quot;time to sJIA flare&quot; will be evaluated as primary endpoint and subjects&#xD;
      will be discontinued once they experience sJIA flare. Once 31 flares are reported the study&#xD;
      will be completed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2018</start_date>
  <completion_date type="Anticipated">March 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 3, 2024</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>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>Time to flare</measure>
    <time_frame>Up to 82 weeks after randomization</time_frame>
    <description>Time to sJIA disease flare in the double-blind phase</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Occurrence of disease flare in double-blind phase</measure>
    <time_frame>Up to 82 weeks after randomization</time_frame>
    <description>disease flare frequency by visit in the double-blind phase.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of corticosteroid tapering at the end of the open-label phase</measure>
    <time_frame>12 to 40 weeks</time_frame>
    <description>Rate of successful corticosteroid tapering.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period</measure>
    <time_frame>12 to 40 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fever (Temp &gt;38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase.</measure>
    <time_frame>Day 3, Day 7, Day 14</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CRP ≤ 10 mg/L at every visit of the open label phase.</measure>
    <time_frame>12 to 40 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>&quot;Absence of fever&quot;, defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase.</measure>
    <time_frame>12 to 40 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase.</measure>
    <time_frame>Up to 82 weeks after randomization.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Arthritis Juvenile Idiopathic</condition>
  <arm_group>
    <arm_group_label>Tofacitinib 5 mg BID</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral, twice daily, tablet or solution.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>In open-label phase: treatment with tofacitinib</intervention_name>
    <description>Treatment with investigational drug</description>
    <arm_group_label>Tofacitinib 5 mg BID</arm_group_label>
    <other_name>CP-690,550</other_name>
    <other_name>Xeljanz</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio</intervention_name>
    <description>Treatment with investigational drug or placebo</description>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_label>Tofacitinib 5 mg BID</arm_group_label>
    <other_name>CP-690,550</other_name>
    <other_name>Xeljanz</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  active sJIA disease according to ILAR criteria before screening and at baseline (Day&#xD;
             1);&#xD;
&#xD;
          -  Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week,&#xD;
             whichever is lower, is permitted;&#xD;
&#xD;
          -  Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30&#xD;
             mg/day, or equivalent, for at least 1 week before the first study drug dose is&#xD;
             permitted.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib.&#xD;
&#xD;
          -  Current symptoms or findings of myocarditis, endocarditis or more than minimal&#xD;
             pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA).&#xD;
             Current symptoms or findings of more than minimal pleuritis with sJIA.&#xD;
&#xD;
          -  Current infection or serious infection within 3 months of study enrollment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <role>Study Director</role>
    <affiliation>Pfizer</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pfizer CT.gov Call Center</last_name>
    <phone>1-800-718-1021</phone>
    <email>ClinicalTrials.gov_Inquiries@pfizer.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Phoenix Children's Hospital</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's National Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AdventHealth</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AdventHealth Pediatric Outpatient Procedures and Sedation</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AHMG Pediatric Rheumatology and Immunology</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>All Children's Hospital Specialty Physicians</name>
      <address>
        <city>Saint Petersburg</city>
        <state>Florida</state>
        <zip>33701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>AU Medical Center</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Augusta University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Ann &amp; Robert H Lurie Children's Hospital of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Lurie Rheumatology Offices</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </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>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center of New York</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cohen Children's Medical Center of New York</name>
      <address>
        <city>New Hyde Park</city>
        <state>New York</state>
        <zip>11040</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </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>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>UNC Children's Hospital</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>UNC Clinical &amp; Translational Research Center</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>UNC Children's Raleigh</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center Investigational Drug Service</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Cincinnati Children's Hospital Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Randall Children's Hospital at Legacy Emanuel</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>PPD Sample Management Department (PK Laboratory)</name>
      <address>
        <city>Middleton</city>
        <state>Wisconsin</state>
        <zip>53562</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto CAICI SRL</name>
      <address>
        <city>Rosario</city>
        <state>Santa FE</state>
        <zip>S2000PBJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>San Miguel de Tucuman</city>
        <state>Tucuman</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hopital Universitaire des Enfants Reine Fabiola (HUDERF)</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP</name>
      <address>
        <city>Botucatu</city>
        <state>SAO Paulo</state>
        <zip>18618-970</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital de Clinicas da UNICAMP</name>
      <address>
        <city>Campinas</city>
        <state>SAO Paulo</state>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina da UNESP</name>
      <address>
        <city>Botucatu</city>
        <state>SÃO Paulo</state>
        <zip>18618-686</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>SPDM - Associacao Paulista para o Desenvolvimento da Medicina</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>SPDM - Associacao Paulista para o Desenvolvimento da Medicina</name>
      <address>
        <city>Sao Paulo</city>
        <zip>04037-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Instituto da Crianca do Hospital das Clinicas da FMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <zip>05409-011</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Alberta Children's Hospital/University of Calgary</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T3B 6A8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>McGill University Health Center, Glen Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Research Institute of McGill University Health Center, Glen site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Québec - Université Laval, Site CHUL</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V 4G2</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>401122</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Guangzhou Women and Children's Medical Center</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510623</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital, Tongji Medical College, Huazhong University of Science &amp; Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Second Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410011</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Xi'an Children's Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shaanxi</state>
        <zip>710003</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Chengdu Women's and Children's Central Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610073</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310057</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beijing Children's Hospital, Capital Medical University/Rheumatology Department</name>
      <address>
        <city>Beijing</city>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Fudan University</name>
      <address>
        <city>Shanghai</city>
        <zip>201102</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Metropolitano</name>
      <address>
        <city>San Jose</city>
        <zip>10103</zip>
        <country>Costa Rica</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Erlangen</name>
      <address>
        <city>Erlangen</city>
        <state>Bayern</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>HELIOS Kliniken Berlin Buch GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>HELIOS Klinikum Berlin Buch GmbH</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Charite - Universitaetsmedizin Berlin, Campus Virchow</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Gesundheit Nord gGmbH</name>
      <address>
        <city>Bremen</city>
        <zip>28177</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Deutsches Zentrum für Kinder- und Jugendrheumatologie</name>
      <address>
        <city>Garmisch-partenkirchen</city>
        <zip>82467</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Sankt Augustin GmbH, Zentrum für Allgemeine Pädiatrie und Neonatologie</name>
      <address>
        <city>Sankt Augustin</city>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>St. Josef-Stift Sendenhorst</name>
      <address>
        <city>Sendenhorst</city>
        <zip>48324</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Semmelweis Egyetem</name>
      <address>
        <city>Budapest</city>
        <zip>1094</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nirmal Hospital Pvt Ltd</name>
      <address>
        <city>Surat</city>
        <state>Gujarat</state>
        <zip>395002</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>Rajinder Nagar</city>
        <state>NEW Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institute of Child Health</name>
      <address>
        <city>Kolkata</city>
        <state>WEST Bengal</state>
        <zip>700017</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Institute of Post Graduate Medical Education and Research &amp; SSKM Hospital</name>
      <address>
        <city>Kolkata</city>
        <state>WEST Bengal</state>
        <zip>700020</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center - Pediatric Clinic</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center- Pharmacy</name>
      <address>
        <city>Kfar Saba</city>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istituto Giannina Gaslini Istituto Pediatrico di Ricovero e Cura a Carattere Scientifico</name>
      <address>
        <city>Genova</city>
        <state>Genoa</state>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Milan</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clínica de Investigacion en Reumatologia y Obesidad, S.C.</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44650</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. Jose Eleuterio Gonzalez&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo LEON</state>
        <zip>64460</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centro de Alta Especialidad en Reumatologia e Investigacion del Potosi, S.C.</name>
      <address>
        <city>San Luis Potosi</city>
        <zip>78213</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>31-503</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>SPZOZ Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi</name>
      <address>
        <city>Lodz</city>
        <zip>91-738</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Centrum Pediatrii im. Jana Pawla II w Sosnowcu Sp. z o.o.</name>
      <address>
        <city>Sosnowiec</city>
        <zip>41-218</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>WIP Warsaw IBD Point Profesor Kierkus</name>
      <address>
        <city>Warsaw</city>
        <zip>00-728</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji im prof dr hab med Eleonory Reicher</name>
      <address>
        <city>Warszawa</city>
        <zip>02-637</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Clinic of FSBEI HE BSMU MoH RF</name>
      <address>
        <city>Ufa</city>
        <state>Republic OF Bashkortostan</state>
        <zip>450083</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Institution &quot;Scientific and Research Rheumatology</name>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Narodny ustav detskych chorob, Detska klinika LF UK a NUDCH</name>
      <address>
        <city>Bratislava</city>
        <zip>833 40</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Detska Fakultna nemocnica Kosice</name>
      <address>
        <city>Kosice</city>
        <zip>04011</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Narodny ustav reumatickych chorob</name>
      <address>
        <city>Piestany</city>
        <zip>921 12</zip>
        <country>Slovakia</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Emmed Research</name>
      <address>
        <city>Pretoria</city>
        <state>Gauteng</state>
        <zip>0002</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Enhancing Care Foundation</name>
      <address>
        <city>Durban</city>
        <state>Kwazulu-natal</state>
        <zip>4301</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Enhancing Care Foundation</name>
      <address>
        <city>Durban</city>
        <state>Kwazulu-natal</state>
        <zip>4302</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Panorama Medical Centre</name>
      <address>
        <city>Cape Town</city>
        <state>Western CAPE</state>
        <zip>7500</zip>
        <country>South Africa</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramon y Cajal</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario y Politecnico La Fe</name>
      <address>
        <city>Valencia</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Hacettepe University Medical Faculty</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa - Cerrahpasa Tip Fakultesi Clinical Research Center</name>
      <address>
        <city>Fatih / Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Umraniye Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <zip>34764</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital Department of Pediatric Rheumatology</name>
      <address>
        <city>Kadikoy / Istanbul</city>
        <zip>34722</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Erciyes Universitesi Tip Fakultesi Hastanesi</name>
      <address>
        <city>Kayseri</city>
        <zip>38039</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location>
    <facility>
      <name>Communal Institution &quot;Dnipropetrovsk Specialized Clinical Medical Center of Mother and Child n.a.</name>
      <address>
        <city>Dnipro</city>
        <zip>49006</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Municipal non-Profit Enterprise</name>
      <address>
        <city>Ivano-Frankivsk</city>
        <zip>76014</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CNE of Lviv Regional Council &quot;Western Ukrainian Specialized Pediatric</name>
      <address>
        <city>Lviv</city>
        <zip>79035</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Vinnytsia Regional Children's Clinical Hospital</name>
      <address>
        <city>Vinnytsia</city>
        <zip>21000</zip>
        <country>Ukraine</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>NHS Greater Glasgow and Clyde, Royal Hospital for Children</name>
      <address>
        <city>Glasgow</city>
        <zip>G51 4TF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>Costa Rica</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Slovakia</country>
    <country>South Africa</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>Ukraine</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Chile</country>
    <country>Netherlands</country>
  </removed_countries>
  <link>
    <url>https://pmiform.com/clinical-trial-info-request?StudyID=A3921165</url>
    <description>To obtain contact information for a study center near you, click here.</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>November 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>September 1, 2023</last_update_submitted>
  <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>systemic Juvenile Idiopathic Arthritis</keyword>
  <keyword>Xeljanz</keyword>
  <keyword>Tofacitinib</keyword>
  <keyword>sJIA</keyword>
  <keyword>CP-690 550</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tofacitinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.</ipd_description>
    <ipd_url>https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000439
org study id: A3921165
secondary id: 2017-002018-29
nct id: NCT03000439
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
A randomized withdrawal study in which responders to open-label treatment with tofacitinib
      will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the
      double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects
      will be discontinued once they experience sJIA flare. Once 31 flares are reported the study
      will be completed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Time to flare
time frame: Up to 82 weeks after randomization
description: Time to sJIA disease flare in the double-blind phase
measure: Occurrence of disease flare in double-blind phase
time frame: Up to 82 weeks after randomization
description: disease flare frequency by visit in the double-blind phase.
measure: Achievement of corticosteroid tapering at the end of the open-label phase
time frame: 12 to 40 weeks
description: Rate of successful corticosteroid tapering.
measure: Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period
time frame: 12 to 40 weeks
measure: Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phase.
time frame: Up to 82 weeks after randomization
measure: Fever (Temp >38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phase.
time frame: Day 3, Day 7, Day 14
measure: CRP ≤ 10 mg/L at every visit of the open label phase.
time frame: 12 to 40 weeks
measure: "Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
measure: Time to first Adapted JIA ACR 30 response in Part 1 of the open label phase.
time frame: 12 to 40 weeks
measure: Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
measure: Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
measure: Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafter.
time frame: Up to 82 weeks after randomization.
measure: Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
measure: Occurrence of inactive disease status and minimal disease activity clinical remission at every visit from Day 7 onward (JADAS 27) in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
measure: Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phase.
time frame: Up to 82 weeks after randomization.
arm group label: Tofacitinib 5 mg BID
arm group type: Experimental
description: oral, twice daily, tablet or solution.
arm group label: Placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: In open-label phase: treatment with tofacitinib
description: Treatment with investigational drug
arm group label: Tofacitinib 5 mg BID
other name: CP-690,550
other name: Xeljanz
intervention type: Drug
intervention name: In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
description: Treatment with investigational drug or placebo
arm group label: Placebo
arm group label: Tofacitinib 5 mg BID
other name: CP-690,550
other name: Xeljanz
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Pfizer CT.gov Call Center
role: Study Director
affiliation: Pfizer
last name: Pfizer CT.gov Call Center
phone: 1-800-718-1021
email: ClinicalTrials.gov_Inquiries@pfizer.com
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Not yet recruiting
facility: 
status: Recruiting
facility: 
status: Recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
country: Argentina
country: Belgium
country: Brazil
country: Canada
country: China
country: Costa Rica
country: Germany
country: Hungary
country: India
country: Israel
country: Italy
country: Mexico
country: Poland
country: Russian Federation
country: Slovakia
country: South Africa
country: Spain
country: Turkey
country: Ukraine
country: United Kingdom
country: United States
country: Chile
country: Netherlands
url: https://pmiform.com/clinical-trial-info-request?StudyID=A3921165
description: To obtain contact information for a study center near you, click here.
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Tofacitinib
sharing ipd: Yes
ipd description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
ipd url: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests