<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/NCT03841357</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100523</org_study_id>
    <nct_id>NCT03841357</nct_id>
  </id_info>
  <brief_title>Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)</brief_title>
  <acronym>Limit-JIA</acronym>
  <official_title>An Open Label, Multi-Center, Phase 3 Efficacy Study of Sub-Q Abatacept in Preventing Extension of Oligoarticular Juvenile Idiopathic Arthritis JIA (Limit-JIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study to test whether a once-weekly injection of abatacept will prevent&#xD;
      the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the&#xD;
      effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual&#xD;
      care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic&#xD;
      medication within 18 months of randomization in children with recent-onset limited JIA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part I enrolled participants into a randomized open-label multicenter trial with a planned&#xD;
      sample size of 306 JIA participants recruited from CARRA Registry sites. Participants were&#xD;
      randomly allocated (1:1) to receive 24 weeks of abatacept plus usual care or usual care&#xD;
      alone. Upon completion of 24 weeks of randomized treatment, each participant was to receive&#xD;
      usual care and undergo follow-up for assessment of outcomes for an additional 12 months.&#xD;
      Planned duration of the study for each participant was 18 months. Due to slow accrual and&#xD;
      apparent loss of equipoise, enrollment into Part I has been discontinued 17February2022 As of&#xD;
      October 29, 2021, 39 participants have been randomized in Part I. Part I participants will&#xD;
      continue follow-up as planned.&#xD;
&#xD;
      Part II is a non-randomized continuation of LIMIT-JIA with planned enrollment of 89 to reach&#xD;
      80 evaluable participants receiving to the abatacept arm. Participants will now receive 24&#xD;
      doses of abatacept plus usual care. Upon completion of 24 doses of treatment, each&#xD;
      participant will receive usual care and undergo follow-up for assessment of outcomes for an&#xD;
      additional 6 months. Planned duration of the study for each participant is 12 months. Part II&#xD;
      will assess the efficacy of abatacept in prevention of disease extension by comparison of&#xD;
      outcomes between participants enrolled in the abatacept arm and 428 CARRA Registry patients&#xD;
      who would have met major eligibility criteria for LIMIT-JIA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 29, 2019</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Joint Count by Physician Exam (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>The number of affected joints involved at protocol specified visits by physician exam.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Joint Count by Physician Exam (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>The number of affected joints involved at protocol specified visits by physician exam.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Number of participants with active anterior uveitis (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Number of participants with active anterior uveitis (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue level as measured by PROMIS (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in fatigue level as measured by PROMIS (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional ability by PROMIS (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in functional ability by PROMIS (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety by PROMIS (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in anxiety by PROMIS (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression by PROMIS (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression by PROMIS (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in global health by PROMIS (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in global health by PROMIS (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in family impact by PedsQL (Part I)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
    <description>The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in family impact by PedsQL (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
    <description>The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in medications side effects by JAMAR (Part 1)</measure>
    <time_frame>Baseline, up to 18 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in medications side effects by JAMAR (Part II)</measure>
    <time_frame>Baseline, up to 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">130</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>Abatacept and Usual Care (Part I)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: Usual Care (Part I)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Abatacept and Usual Care (Part II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Abatacept Injection</intervention_name>
    <description>Supplied as a weekly injection via a pre-filled syringe</description>
    <arm_group_label>Abatacept and Usual Care (Part I)</arm_group_label>
    <arm_group_label>Abatacept and Usual Care (Part II)</arm_group_label>
    <other_name>Orencia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual Care</intervention_name>
    <description>Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs</description>
    <arm_group_label>Abatacept and Usual Care (Part I)</arm_group_label>
    <arm_group_label>Abatacept and Usual Care (Part II)</arm_group_label>
    <arm_group_label>Active Comparator: Usual Care (Part I)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        To be eligible for this trial, participants must meet all of the following criteria in&#xD;
        order to be include in the study:&#xD;
&#xD;
          1. Age ≥ 2 years old and ≤16.5 years old&#xD;
&#xD;
          2. Clinical diagnosis of JIA by a pediatric rheumatologist within the past 6 months&#xD;
&#xD;
          3. Arthritis affecting ≤4 joints between disease onset and enrollment&#xD;
&#xD;
          4. Enrollment in the CARRA Registry&#xD;
&#xD;
          5. Participants of childbearing potential must agree to remain abstinent or agree to use&#xD;
             an effective and medically acceptable form of birth control from the time of written&#xD;
             or verbal assent to at least 66 days after taking the last dose of study drug.&#xD;
&#xD;
          6. Weight ≥50 kg (Canadian Sites only) ¹ Enrollment is defined as having signed consent&#xD;
             to participate in the Limit-JIA study.&#xD;
&#xD;
        The presence of any of the following will exclude a study participant from inclusion in the&#xD;
        study:&#xD;
&#xD;
          1. 1. Systemic JIA as defined by 2004 ILAR criteria1&#xD;
&#xD;
          2. Sacroiliitis (clinical or radiographic)&#xD;
&#xD;
          3. Inflammatory bowel disease (IBD)&#xD;
&#xD;
          4. History of psoriasis or currently active psoriasis&#xD;
&#xD;
          5. History of uveitis or currently active uveitis&#xD;
&#xD;
          6. Prior treatment with systemic medication(s) for JIA (e.g. one or more of the&#xD;
             following: DMARD or biologic medication)&#xD;
&#xD;
          7. Current or previous (within 30 days of enrollment) treatment with systemic&#xD;
             glucocorticoids (A short course of oral prednisone [≤ 14 days] is allowed)&#xD;
&#xD;
          8. History of active or chronic liver disease&#xD;
&#xD;
          9. Chronic or acute renal disorder&#xD;
&#xD;
         10. AST (SGOT), ALT (SGPT) or BUN &gt;2 x ULN (upper limit of normal) or creatinine &gt;1.5&#xD;
             mg/dL or any other laboratory abnormality considered by the examining physician to be&#xD;
             clinically significant within 2 months of the enrollment visit&#xD;
&#xD;
         11. Presence of any medical or psychological condition or laboratory result which would&#xD;
             make the participant, in the opinion of the investigator, unsuitable for the study&#xD;
&#xD;
         12. Participation in another concurrent clinical interventional study within 30 days of&#xD;
             enrollment&#xD;
&#xD;
         13. Known positive human immunodeficiency virus (HIV)&#xD;
&#xD;
         14. Received a live virus vaccine within 1 month of the baseline visit&#xD;
&#xD;
         15. Current or prior positive Purified Protein Derivative (PPD) test or Quantiferon Gold&#xD;
             TB&#xD;
&#xD;
         16. Pregnant, breast feeding, or planned breast feeding during the study duration&#xD;
&#xD;
         17. Planned transfer to non-participating pediatric rheumatology center or adult&#xD;
             rheumatologist in the next 12 months&#xD;
&#xD;
         18. Active malignancy of any type or history of malignancy&#xD;
&#xD;
         19. Chronic or active infection or any major episode of infection requiring&#xD;
             hospitalization or treatment with intravenous (IV) antibiotics within 30 days or oral&#xD;
             antibiotics within 14 days prior to screening&#xD;
&#xD;
         20. Primary language other than English or Spanish&#xD;
&#xD;
         21. Positive for Hepatitis B surface antigen or core antibody&#xD;
&#xD;
         22. &lt;10 Kg in weight&#xD;
&#xD;
         23. If a potential subject has symptoms consistent with COVID-19 and/or known COVID-19&#xD;
             exposure at screening, it is recommended that the site follow CDC guidance regarding&#xD;
             testing and quarantine requirements. The subject can be re-screened when there is no&#xD;
             longer concern for active infection. A subject with a positive COVID -19 test may be&#xD;
             re-screened.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Schanberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eveline Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Valarie Morrow</last_name>
    <phone>9197248931</phone>
    <email>valarie.morrow@duke.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of California at San Francisco Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94143</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Emily von Scheven, MD</last_name>
      <email>evonsche@peds.ucsf.edu</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Katharine Moore, MD</last_name>
      <email>katharine.moore@childrenscolorado.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shands at the University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melissa Elder, MD</last_name>
      <email>elderme@peds.ufl.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Childrens Memorial Hospital/ Ann and Robert Lurie Children's Hospital</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of Chicago</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Riley Hospital for Children at Indiana University Health</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacey Tarvin, MD</last_name>
      <email>starvin@iupui.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals of Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sandy Hong, MD</last_name>
      <email>sandy-hong@uiowa.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Louisville School of Medicine/ Norton Charities Pediatric Clinical Research Unit</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kenneth Schikler, MD</last_name>
      <email>kenneth.schikler@louisville.edu</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Mary Beth Son, MD</last_name>
      <email>marybeth.son@childrens.harvard.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Minnesota; Children's Hospital and Clinics of Minnesota</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colleen Correll, MD</last_name>
      <email>corr0250@umn.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Matthew Basiaga, MD</last_name>
      <email>basiaga.matthew@mayo.edu</email>
    </contact>
  </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>Recruiting</status>
    <contact>
      <last_name>Sivia Lapidus, MD</last_name>
      <email>sivia.lapidus@hmhn.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Pediatric Specialty Center at Saint Barnabas/RWJ Barnabas Health</name>
      <address>
        <city>West Orange</city>
        <state>New Jersey</state>
        <zip>07052</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Children's Hospital at Montefiore/ Albert Einstein University Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dawn Wahezi, MD</last_name>
      <email>dwahezi@montefiore.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital of Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>University of North Carolina</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27514</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eveline Wu, MD</last_name>
      <email>eveline.wu@unc.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Levine Children's Hospital/ Carolina Medical Center</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28203</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</status>
  </location>
  <location>
    <facility>
      <name>Duke Children's Hospital and Health Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Withdrawn</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>
    <contact>
      <last_name>Sheila Angeles-Han, MD</last_name>
      <email>sheila.angeles-han@cchmc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>MetroHealth System</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hulya Bukulmez, MD</last_name>
      <email>hbukulmez@metrohealth.org</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Stacy Ardoin</last_name>
      <email>stacy.ardoin@nationwidechildrens.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Philadelphia</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jay Mehta, MD</last_name>
      <email>mehtaj@email.chop.edu</email>
    </contact>
  </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>
    <status>Recruiting</status>
    <contact>
      <last_name>Brent Graham, MD</last_name>
      <email>brent.graham@vumc.org</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Utah</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84158</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christi Inman, MD</last_name>
      <email>cj.inman@hsc.utah.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98105</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kabita Nanda, MD</last_name>
      <email>kabita.nanda@seattlechildrens.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyarthritis</keyword>
  <keyword>abatacept</keyword>
  <keyword>uveitis</keyword>
  <keyword>prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abatacept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03841357
org study id: Pro00100523
nct id: NCT03841357
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a research study to test whether a once-weekly injection of abatacept will prevent
      the progression of Juvenile Idiopathic Arthritis (JIA) to a more severe form. To evaluate the
      effectiveness of a 24-week course of treatment with abatacept plus usual care versus usual
      care to prevent polyarthritis (≥5 joints), uveitis, or treatment with other systemic
      medication within 18 months of randomization in children with recent-onset limited JIA.
Part I enrolled participants into a randomized open-label multicenter trial with a planned
      sample size of 306 JIA participants recruited from CARRA Registry sites. Participants were
      randomly allocated (1:1) to receive 24 weeks of abatacept plus usual care or usual care
      alone. Upon completion of 24 weeks of randomized treatment, each participant was to receive
      usual care and undergo follow-up for assessment of outcomes for an additional 12 months.
      Planned duration of the study for each participant was 18 months. Due to slow accrual and
      apparent loss of equipoise, enrollment into Part I has been discontinued 17February2022 As of
      October 29, 2021, 39 participants have been randomized in Part I. Part I participants will
      continue follow-up as planned.

      Part II is a non-randomized continuation of LIMIT-JIA with planned enrollment of 89 to reach
      80 evaluable participants receiving to the abatacept arm. Participants will now receive 24
      doses of abatacept plus usual care. Upon completion of 24 doses of treatment, each
      participant will receive usual care and undergo follow-up for assessment of outcomes for an
      additional 6 months. Planned duration of the study for each participant is 12 months. Part II
      will assess the efficacy of abatacept in prevention of disease extension by comparison of
      outcomes between participants enrolled in the abatacept arm and 428 CARRA Registry patients
      who would have met major eligibility criteria for LIMIT-JIA.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Joint Count by Physician Exam (Part I)
time frame: Baseline, up to 18 months
description: The number of affected joints involved at protocol specified visits by physician exam.
measure: Change in Joint Count by Physician Exam (Part II)
time frame: Baseline, up to 12 months
description: The number of affected joints involved at protocol specified visits by physician exam.
measure: Change in Number of participants with active anterior uveitis (Part I)
time frame: Baseline, up to 18 months
description: The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
measure: Change in Number of participants with active anterior uveitis (Part II)
time frame: Baseline, up to 12 months
description: The presence of active anterior uveitis, defined according to the Standardization of Uveitis Nomenclature for Reporting Clinical Data (SUN criteria) as the presence of one or more cells in each 1mm x 1mm slit beam field,84 will be assessed at standard of care ophthalmology visits
measure: Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part I)
time frame: Baseline, up to 18 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in pain score as measured by PROMIS (patient reported outcome measurement system) (Part II)
time frame: Baseline, up to 12 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in fatigue level as measured by PROMIS (Part I)
time frame: Baseline, up to 18 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in fatigue level as measured by PROMIS (Part II)
time frame: Baseline, up to 12 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in functional ability by PROMIS (Part I)
time frame: Baseline, up to 18 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in functional ability by PROMIS (Part II)
time frame: Baseline, up to 12 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in anxiety by PROMIS (Part I)
time frame: Baseline, up to 18 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in anxiety by PROMIS (Part II)
time frame: Baseline, up to 12 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in depression by PROMIS (Part I)
time frame: Baseline, up to 18 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in depression by PROMIS (Part II)
time frame: Baseline, up to 12 months
description: We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in global health by PROMIS (Part I)
time frame: Baseline, up to 18 months
description: Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in global health by PROMIS (Part II)
time frame: Baseline, up to 12 months
description: Global health is defined as overall well being; We will use The Patient Reported Outcomes Measurement Information System (PROMIS), to compare patient and caregiver reported outcomes between the groups. PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centeredmeasures that evaluates and monitors physical, mental, and social health in adults and children.
measure: Change in family impact by PedsQL (Part I)
time frame: Baseline, up to 18 months
description: The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
measure: Change in family impact by PedsQL (Part II)
time frame: Baseline, up to 12 months
description: The PedsQL (Pediatric Quality of Life InventoryTM) Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions.
measure: Change in medications side effects by JAMAR (Part 1)
time frame: Baseline, up to 18 months
measure: Change in medications side effects by JAMAR (Part II)
time frame: Baseline, up to 12 months
arm group label: Abatacept and Usual Care (Part I)
arm group type: Experimental
description: Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider
arm group label: Active Comparator: Usual Care (Part I)
arm group type: Active Comparator
description: Usual care includes steroid joint injections and treatment with non-steroidal anti-inflammatory drugs at the discretion of the treating provider
arm group label: Abatacept and Usual Care (Part II)
arm group type: Experimental
description: Weekly abatacept injection at standard dosing for weight plus usual care with steroid joint injection and non-steroidal anti-inflammatory drugs per the discretion of the treating provider
intervention type: Drug
intervention name: Abatacept Injection
description: Supplied as a weekly injection via a pre-filled syringe
arm group label: Abatacept and Usual Care (Part I)
arm group label: Abatacept and Usual Care (Part II)
other name: Orencia
intervention type: Other
intervention name: Usual Care
description: Usual care will be defined by the clinical management team but includes steroid joint injections and non- steroidal anti-inflammatory drugs
arm group label: Abatacept and Usual Care (Part I)
arm group label: Abatacept and Usual Care (Part II)
arm group label: Active Comparator: Usual Care (Part I)
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Laura Schanberg, MD
role: Principal Investigator
affiliation: Duke University
last name: Eveline Wu, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Valarie Morrow
phone: 9197248931
email: valarie.morrow@duke.edu
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Withdrawn
facility: 
status: Withdrawn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile
mesh term: Abatacept
sharing ipd: No